qEzXyKha

1-- 12/15/14 - GCP Redesign Rollout
2-- STAGING: X
3-- QA: X
4-- PRODUCTION: X
5
6-- Add Course 4
7INSERT INTO `gcp_courses` (`ID_COURSE`, `name`, `created_at`)
8VALUES
9	(4,'Redesign', now());
10
11--- Associate the sections from course 3 to course 4.
12INSERT INTO `gcp_sections_courses` (`ID_SECTION`, `ID_COURSE`, `is_optional`, `sort_order`)
13    SELECT `ID_SECTION`, 4, `is_optional`, `sort_order`
14    FROM `gcp_sections_courses`
15    WHERE `gcp_sections_courses`.`ID_COURSE` = 3;
16
17-- Drop old questions table
18DROP TABLE IF EXISTS `gcp_questions`;
19
20-- Create new questions table
21CREATE TABLE `gcp_questions` (
22  `ID_QUESTION` int(11) NOT NULL AUTO_INCREMENT,
23  `ID_OLD` varchar(100) DEFAULT NULL,
24  `question` text,
25  `answer1` text,
26  `answer2` text,
27  `answer3` text,
28  `answer4` text,
29  `answer5` text,
30  `answer6` text,
31  `answer7` text,
32  `correct_answer` int(11) DEFAULT '0',
33  `sort_order` decimal(11,2) DEFAULT '0.00',
34  `created_at` timestamp NULL DEFAULT CURRENT_TIMESTAMP,
35  PRIMARY KEY (`ID_QUESTION`)
36) ENGINE=MyISAM DEFAULT CHARSET=latin1;
37
38LOCK TABLES `gcp_questions` WRITE;
39/*!40000 ALTER TABLE `gcp_questions` DISABLE KEYS */;
40
41-- Add new questions
42INSERT INTO `gcp_questions` (`ID_QUESTION`, `ID_OLD`, `question`, `answer1`, `answer2`, `answer3`, `answer4`, `answer5`, `answer6`, `answer7`, `correct_answer`, `sort_order`, `created_at`)
43VALUES
44	(1,NULL,'The primary purpose of the Institutional Review Board (IRB) is to:','Investigate allegations of research misconduct.','Administer compensation for participation to study volunteers.','Protect the rights and welfare of research participants.','All of the above.','','','',3,0.00,'2014-10-02 10:58:06'),
45	(2,NULL,'Regulations require IRBs to review ongoing research studies:','Every 3 months.','Every 6 months.','Once a year.','As often as the IRB deems appropriate, but not less frequently than once per year.','','','',3,0.00,'2014-10-02 10:58:06'),
46	(3,NULL,'The three key principles that serve as the criteria for IRB approval of research can be found in which of the following documents:','Belmont Report','Code of Federal Regulations (CFR)','ICH Good Clinical Practice guidelines (ICH GCPs)','Declaration of Helsinki','','','',1,0.00,'2014-10-02 10:58:06'),
47	(4,NULL,'A protocol that has been previously reviewed by the full IRB is always eligible for expedited review.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:58:06'),
48	(5,NULL,'All of the following statements are True or False:\n     <ul>\n     <li>The purpose of an Institutional Review Board (IRB) is to safeguard the rights, safety, and well-being of all human research participants.</li>\n     <li>Any federally funded research involving human participants must be reviewed and approved by an IRB.</li>\n     <li>Any clinical investigation involving a product regulated by the FDA must be reviewed and approved by an IRB.</li>\n     <li>An IRB has the authority to approve or disapprove all human research activities that fall within its jurisdiction. It also has the authority to suspend or terminate a research study that it previously approved.</li>\n     </ul>','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 10:58:06'),
49	(6,NULL,'For an IRB review to be required, clinical research must be:','Federally funded.','Involve a product regulated by the FDA.','Fall under local institutional rules requiring IRB approval.','Any or all of the above A, B or C.','','','',4,0.00,'2014-10-02 10:58:06'),
50	(7,NULL,'An IRB may suspend or terminate an ongoing clinical study if:','Subjects are not being enrolled quickly enough.','A drug being used in the trial is approved by FDA.','Instructions from the IRB are not being followed. ','The clinical trial sponsor conducts an audit at the site.','','','',3,0.00,'2014-10-02 10:58:06'),
51	(8,NULL,'IRB members must:','All be physicians who can assess subject safety.','Be affiliated with the institute or study site conducting the study.','Have the qualifications and experience to review and evaluate the scientific, medical, behavioral, social, legal, and ethical aspects of a proposed study.','Be investigators on the study.','','','',3,0.00,'2014-10-02 10:58:06'),
52	(9,NULL,'What information should be provided to an IRB for review at the initiation of a study?  Choose the best response.','A synopsis of the study and an outline of the advertisement to recruit subjects, including how much they will be paid.','The informed consent form.','The study protocol (and amendments), the information to be given to the subject (informed consent, advertisements), the Investigator Brochure (or drug label), any other relevant safety information, and an outline of the qualifications of the lnvestigator.','The study protocol (and amendments) and the Investigator Brochure.','','','',3,0.00,'2014-10-02 10:58:06'),
53	(10,NULL,'An IRB may perform an expedited review of a protocol or informed consent form change if the change involves no more than minimal risk to study participants.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 10:58:06'),
54	(11,NULL,'Changes to a study protocol, via a protocol amendment, can be implemented at the site as soon as it is submitted to the IRB.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:58:06'),
55	(12,NULL,'An ongoing clinical protocol at your site includes weekly blood draws to assess an exploratory endpoint.  Unfortunately, participants are not happy about visiting the clinic weekly, and they are considering dropping out.  Therefore, a protocol amendment is being prepared to remove the weekly blood draw.  This change can be implemented:','Immediately, as it is not a safety assessment.','Once the protocol is finalized and submitted to the FDA.','Once the protocol and consent form updates are approved by the IRB.','As soon as the study sponsor advises that their decision is final to remove these blood draws.','','','',3,0.00,'2014-10-02 10:58:06'),
56	(13,NULL,'The purpose of an IRB is to safeguard the rights, safety, and well-being of all human research participants.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 10:58:06'),
57	(14,NULL,'A clinical investigator cannot be a member of the IRB.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:58:06'),
58	(15,NULL,'After the IRB reviews and approves your protocol, informed consent, and associated documents, you should receive: ','A phone call telling you the study can now proceed.','A personal visit from the IRB chair telling you how excited he/she is about your research.','Written notification of the IRB decision and the approved versions of the protocol and informed consent forms.','Nothing.  If you do not receive a response in 30 days, you can proceed with your study.','','','',3,0.00,'2014-10-02 10:58:06'),
59	(16,NULL,'If already serving as a member of the IRB, a clinical investigator can participate in the review of her own clinical protocol.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:58:06'),
60	(17,NULL,'The site staff has prepared a postcard to be sent to past study participants telling them about a new study that they may have an interested in.  This postcard does not have to be reviewed by the IRB.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:58:06'),
61	(18,NULL,'All members serving on an IRB that oversees human research at an institution must be employed by or affiliated with that institution.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:58:06'),
62	(19,NULL,'The three key principles that underlie the current system of human research protections (respect for persons, beneficence (being charitable or kind), and justice) were established in which of the following:','The Belmont Report','International Conference on Harmonization','HIPAA','Code of Federal Regulations (CFR)','','','',1,0.00,'2014-10-02 10:58:06'),
63	(20,NULL,'Informed consent is:','The process by which a person voluntarily agrees to participate in a research study after being fully informed about the study.','The legal document that explains the study.','A document stating that the study information was presented orally to the person.','All of the above.','','','',1,0.00,'2014-10-02 10:58:25'),
64	(21,NULL,'To document that the research participant has voluntarily agreed to participate in the study, the research participant must:','Pass a test of comprehension.','Meet with the institution\'s Institutional Review Board (IRB).','Sign and date the Informed Consent Form.','All of the above.','','','',3,0.00,'2014-10-02 10:58:25'),
65	(22,NULL,'The Informed Consent form can be used to consent research participants before the IRB reviews and approves the language.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:58:25'),
66	(23,NULL,'If the research participant is a minor (under the age of 18), all of the following must occur before the individual can participate in the research study except:','The parent/legal guardian must give permission for the minor to participate.','The minor must agree to participate in the research.','A judge gives permission for the minor to participate in the research.','The IRB has approved participation in the research study by minors.','','','',3,0.00,'2014-10-02 10:58:25'),
67	(24,NULL,'If an individual agrees to participate in a research study because he or she believes that harm or punishment will result for refusing to participate in the study, the individual\'s decision to participate was:','Obtained voluntarily.','Influenced improperly (coerced).','Neither.','','','','',2,0.00,'2014-10-02 10:58:25'),
68	(25,NULL,'All of the following safeguards for the protection of prisoners involved in research are true except:','The IRB must approve the study as prisoner research.','The study must present no more than minimal risk to the participants.','The IRB that reviews and approves the study must not include prisoners or prisoner advocates its membership.','The research must involve practices intended to improve the health or well-being of the participants.','','','',3,0.00,'2014-10-02 10:58:25'),
69	(26,NULL,'A person who has a court-appointed legal guardian or who has been determined by a court to be legally incompetent can sign an informed consent form if she/he has the capacity to make a decision.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:58:25'),
70	(27,NULL,'The following factors impact the capacity to consent except:','Age','Cognitive (mental) impairment','Illnes','Financial factors','','','',4,0.00,'2014-10-02 10:58:25'),
71	(28,NULL,'As part of the consent, each participant must be informed that she/he has a right to withdraw only at the beginning of a study.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:58:25'),
72	(29,NULL,'Because of being incarcerated, prisoners may be under constraints that potentially affect their ability to make a voluntary decision about whether or not to participate in a study.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 10:58:25'),
73	(30,NULL,'There are many historical examples of blatant coercion where:','Participants believed that they would be harmed or punished for refusing to take part in research.','Relationships existed that involved dependence or unequal power between those carrying out the research and potential participants.','Research team members designated to explain the study to the participant linked participation to employment or receipt of benefits.','All of the above.','','','',4,0.00,'2014-10-02 10:58:25'),
74	(31,NULL,'Failure to comply with general requirements for informed consent and documentation of informed consent may result in suspension of a study.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 10:58:25'),
75	(32,NULL,'The following are steps to take with errors in the informed consent process except:','Errors are considered protocol violations and must be reported to the relevant IRB.','Errors are very uncommon and always result in suspension of the study.','Errors must be dealt with openly and honestly.','Once errors are identified, a description must be provided of the action taken to correct the error and prevent it from occurring again.','','','',2,0.00,'2014-10-02 10:58:25'),
76	(33,NULL,'The consent form is signed by the participant but is missing the participant\'s initials in several places. Which strategy helps to prevent this from occurring in the future with other participants?','Conduct consent interviews in a quiet, separate room with no distractions or interruptions.','The person obtaining the participant\'s consent must be present when the form is signed.','Create and use a checklist to ensure that every detail in the informed consent process is completed.','All of the above.','','','',4,0.00,'2014-10-02 10:58:25'),
77	(34,NULL,'When an original consent form has been lost, the only steps that must be taken are that study staff report the loss immediately to the IRB, the sponsor, and get another signed as soon as possible. ','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:58:25'),
78	(35,NULL,'Requirements for documentation of informed consent (set forth in 45 CFR 46.117, 21 CFR 50.27, and ICH GCP 4.8) are:','The IRB must approve the consent form.','The participant or the participant\'s legally authorized representative must sign the current version of the IRB approved consent form.','A copy must be given to the person that signs it.','All of the above.','','','',4,0.00,'2014-10-02 10:58:25'),
79	(36,NULL,'According to 45 CFR 46 Subpart B, when research involves pregnant women as participants, both mother and father must always be informed about any potential impact of the research on the fetus.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:58:25'),
80	(37,NULL,'Certificates of Confidentiality (CoC) do not prevent investigators from releasing personal information without participant consent in which of the following cases:','Matters such as child abuse or neglect.','Reportable communicable diseases.','Threatened violence or harm to self or others.','All of the above.','','','',4,0.00,'2014-10-02 10:58:25'),
81	(38,NULL,'Which of the following doesn\'t apply when new information is available to researchers regarding the study medication, etc.:','Study participants will be advised promptly if the researchers find any new information that might affect them.','Participants do not have to sign a new consent form.','Participants do not have to continue taking part in the study.','Participants will not incur penalties or loss of benefits if they withdraw from the study.','','','',2,0.00,'2014-10-02 10:58:25'),
82	(39,NULL,'Jan W. is a former Marine who is on parole. He has been invited to participate in a study on the effects of an investigational medication on post-traumatic shock in Gulf War veterans. He is told a certain amount of blood and several urine samples will be taken sometime during the study. He is not told when these tests will occur and it has not been explained to him that any positive test results for other drugs must be reported to his parole officer. Has Jan W. been properly informed and consented for the study?','YES','NO','','','','','',2,0.00,'2014-10-02 10:58:25'),
83	(40,NULL,'Is the following statement true? All informed consent documents should be written in non-technical language that potential participants would understand; rather, the language should be consistent with the proposed participants educational level, cultural views, and familiarity with research.','Yes, the statement is true.','No, the statement is false.','','','','','',1,0.00,'2014-10-02 10:58:25'),
84	(41,NULL,'The following types of alcohol and drug abuse patient records should be treated as protected information:','Identity.','Diagnosis.','Prognosis.','Treatment.','All of the above.','','',5,0.00,'2014-10-02 10:58:41'),
85	(42,NULL,'All of the following practices ensure the confidentiality of research participants except:','Properly dispose of all paper documents containing identifiers (SSN, address, DOB, etc.).','Use the participant\'s SSN instead of the participant\'s full name.','Require passwords to access computerized records.','Store paper records in a secure place (secure room, locked cabinet, safe, etc.).','All of the above.','','',2,0.00,'2014-10-02 10:58:41'),
86	(43,NULL,'Each Community Treatment Program (CTP), taking part in a NIDA CTN study, is responsible for obtaining its own Certificate of Confidentiality.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:58:41'),
87	(44,NULL,'All of the following protected health information (PHI) is subject to the HIPAA Privacy Rule except:','E-mail address.','Telephone and Fax numbers.','Zodiac signs.','Name.','Social Security Number (SSN).','','',3,0.00,'2014-10-02 10:58:41'),
88	(45,NULL,'Researchers are not required to account for disclosures of protected health information (PHI) when:','The participant authorizes disclosure.','The information is provided as a complete data set.','The information contains participant identifiers.','','','','',1,0.00,'2014-10-02 10:58:41'),
89	(46,NULL,'Disclosure of protected information is only a breach of confidentiality when disclosed in writing.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:58:41'),
90	(47,NULL,'Choose the Code of Federal Regulations (CFR) that identifies certain exceptions to confidentiality requirements for alcohol and drug abuse patient records.','21 CFR 11.12.','21 CFR 54.12.','42 CFR 2.12.','','','','',3,0.00,'2014-10-02 10:58:41'),
91	(48,NULL,'Circumstances determined as exceptions to the Code of Federal Regulations (CFR) on confidentiality requirements for alcohol and drug abuse patient records include all of the following except:','Participant is a danger to self or others.','Participant needs non-emergent medical care.','Participant has a communicable disease.','Participant has committed or threatened to commit criminal activity.','','','',2,0.00,'2014-10-02 10:58:41'),
92	(49,NULL,'Medical records, paper based and electronic, are subject to disclosure and confidentiality requirements.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 10:58:41'),
93	(50,NULL,'Study participants trust researchers with their personal health information (PHI), as such researchers use various practices to ensure participant confidentiality, such as:','Disposing properly of all documentation with PHI identifiers.','Maintaining a notebook of all participant addresses and names in the researcher\'s personal papers.','Storing participant paper records in a locked cabinet.','Assigning security codes to electronic records.','A, C, and D.','','',5,0.00,'2014-10-02 10:58:41'),
94	(51,NULL,'Researchers are required to maintain confidentiality requirements, even when a participant commits a crime.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:58:41'),
95	(52,NULL,'Based on confidentiality regulations, written records must be:','Maintained in a secure location, such as a locked file room, cabinet, or safe.','Stored in an open location, accessible to all staff at the research site.','Accessible to study participants at all times.','','','','',1,0.00,'2014-10-02 10:58:41'),
96	(53,NULL,'The document that provides protection for the privacy of study participants in alcohol and drug abuse research studies is called:','Affidavit','Certificate of Confidentiality','Disclosure Certificate','Confidentiality Agreement Form','','','',2,0.00,'2014-10-02 10:58:41'),
97	(54,NULL,'Certificates of Confidentiality may contribute to increased enrollment in trials due to assurance of  participant privacy.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 10:58:41'),
98	(55,NULL,'What year was the Health Insurance Portability and Accountability Act (HIPAA) passed by the U.S. Congress?','1975','2000','1996','1990','','','',3,0.00,'2014-10-02 10:58:41'),
99	(56,NULL,'CTN research facilities are not required to adhere to the HIPAA Privacy Rule established by DHHS in 2003.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:58:41'),
100	(57,NULL,'The HIPAA Privacy Rule applies to which of the following individual identifiable health information:','Fingerprints and voice prints','License and license plate numbers','Names','Dates','All of the above.','','',5,0.00,'2014-10-02 10:58:41'),
101	(58,NULL,'Public Policy Purposes are the exceptions where the HIPAA Privacy Rule permits disclosure of PHI without participant authorization for the following events, except:','When an entity requests disclosure in writing, but without a court order.','For organ donation.','For research purposes.','When required by law, for national security, or intelligence activities.','','','',1,0.00,'2014-10-02 10:58:41'),
102	(59,NULL,'In research, once a program obtains a participant\'s authorization for disclosure of PHI, there is no need to keep track of disclosures made.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 10:58:41'),
103	(60,NULL,'When a study participant no longer wants to disclose PHI, what can be done?','It is too late to make changes after consent has been given.','The participant must petition removal through court order.','The participant may revoke authorization for future disclosures of PHI.','','','','',3,0.00,'2014-10-02 10:58:41'),
104	(61,NULL,'The person(s) responsible for assuring the safety and rights of study participants in a CTN protocol is:','NIDA Study Medical Officer.','Study Medical Monitor.','Node Principal Investigator.','Protocol Principal Investigator.','Lead Investigator.','Data and Safety Monitoring Board.','All of the above.',7,0.00,'2014-10-02 10:59:01'),
105	(62,NULL,'The severity of an adverse event (AE) is the same as its seriousness.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:59:01'),
106	(63,NULL,'All serious adverse events (SAEs) must be reported to the CTP\'s Institutional Review Board (IRB).','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 10:59:01'),
107	(64,NULL,'A serious adverse event (SAE) should be reported to the Sponsor within what period of time after learning of the event?','5 day','2 weeks','24 hours','30 days','72 hours','','',3,0.00,'2014-10-02 10:59:01'),
108	(65,NULL,'This is not one of the serious advent event (SAE) criteria.','Death','Life threatening','Pregnancy','Hospitalization','','','',3,0.00,'2014-10-02 10:59:01'),
109	(66,NULL,'A participant reported migraine headache and missed work for a day. Is this an AE?','Check baseline medical history','Assess the severity level','Assess if there is change from baseline.','All of the above.','','','',4,0.00,'2014-10-02 10:59:01'),
110	(67,NULL,'The site became aware of a participant\'s death searching through public records.','Report this as a Serious Adverse Event (SAE).','Report this as an Adverse Event (AE).','Do nothing.','Contact the Study Physician for instructions on next steps.','','','',1,0.00,'2014-10-02 10:59:01'),
111	(68,NULL,'The participant missed the final study visit as he was hospitalized for pneumonia but reported to the study clinic a week later.','Report it as SAE.','Report it as AE.','Clearly out of window, no need to report.','Follow the protocol reporting guidelines.','','','',4,0.00,'2014-10-02 10:59:01'),
112	(69,NULL,'The site investigator receives a copy of an expedited safety report that represents an increased risk to the study  participants.','File it in regulatory binder.','Report to local IRB.','Inform all participants.','All of the above.','','','',4,0.00,'2014-10-02 10:59:01'),
113	(70,NULL,'A serious adverse event (SAE) should be reported to the local IRB within what period of time after learning of the event?','5 days','2 weeks','24 hours','Follow the local IRB reporting guidelines.','','','',4,0.00,'2014-10-02 10:59:01'),
114	(71,NULL,'A participant is admitted to a hospital for preplanned cosmetic surgery. Report it as a serious adverse event.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:59:01'),
115	(72,NULL,'Mandatory elements in the definition of an adverse event include the following EXCEPT:','Untoward medical occurrence.','Use of pharmaceutical product or a study intervention.','Patient or clinical investigation subject involvement.','Causal relationship with pharmaceutical product.','All the above are correct.','','',3,0.00,'2014-10-02 10:59:01'),
116	(73,NULL,'Examples of adverse event include the following EXCEPT:','Decreased blood sodium.','Anxiety.','Worsening headache.','Enlarged thyroid on physical examination.','Interaction between food and pharmaceutical product reducing absorption of the latter.','Damaged wheelchair.','All the above are correct.',6,0.00,'2014-10-02 10:59:01'),
117	(74,NULL,'Non-medical events such as arrest, imprisonment and violence to others may be captured as adverse events:','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 10:59:01'),
118	(75,NULL,'Which of the following is INCORRECT?','An adverse reaction or suspected adverse reaction implies a causal relationship with the study product.','An adverse event is assessed as associated with the use of a study product when there is a reasonable possibility that the adverse event has been caused by the study product,  i.e., there are facts (evidence) or arguments to suggest a causal relationship.','A severe adverse event implies it is serious.','An abnormal laboratory result may be a serious adverse event.','An adverse event listed in the drug\'s current labeling is considered unexpected if it is more severe or is reported at a higher level of specificity.','','',3,0.00,'2014-10-02 10:59:01'),
119	(76,NULL,'Which source document may NOT be used to determine whether an adverse event is expected or not in clinical studies in which an investigational new drug is used?','Investigator Brochure','Protocol','Informed Consent Form','Annual Safety Report','All of the above may be used.','','',4,0.00,'2014-10-02 10:59:01'),
120	(77,NULL,'Who CANNOT report an adverse event (AE):','Participant','Participant\'s spouse','Caregiver','Participant\'s family member','Research Nurse','All of the above can report an AE.','',6,0.00,'2014-10-02 10:59:01'),
121	(78,NULL,'Which adverse event feature is NOT used to determine whether expedited reporting to the FDA by the Sponsor is required?','Seriousness (threatening life or function)','Expectedness','Causal relationship with study product','Severity','All of the above.','','',4,0.00,'2014-10-02 10:59:01'),
122	(79,NULL,'Which FDA expedited reporting timeline below is INCORRECT?','Life-threatening, serious, unexpected, related adverse events - 7 calendar days.','Fatal, serious, unexpected, unrelated adverse events - expedited reporting not required.','Life-threatening, serious, expected, related adverse events - 15 calendar days.','Fatal, serious, unexpected, related adverse events - 7 calendar days.','Non-fatal and non-life-threatening, serious, expected, related adverse events - 15 calendar days.','','',3,0.00,'2014-10-02 10:59:01'),
123	(80,NULL,'For studies of investigational new drug, NIDA requires that Lead Investigators distribute a safety report to participating Investigators within 24 hours in the following situations EXCEPT:','The adverse event is considered serious, unexpected, and causally related to the investigational new drug.','The adverse event requires a protocol revision.','The adverse event requires an informed consent form amendment.','The adverse event requires termination of the study or suspension of enrollment.','All of the above are correct.','','',5,0.00,'2014-10-02 10:59:01'),
124	(81,NULL,'A serious adverse event (SAE) does NOT need to be reported to NIDA or designee within 24 hours in which of the following situation:','The investigator considers the SAE unrelated to study intervention.','The SAE is non-fatal and non-life-threatening.','The SAE occurs in a behavioral study.','The SAE occurs in a non-Investigational New Drug study.','The SAE occurs in the post-treatment observation period.','None of the above.','',5,0.00,'2014-10-02 10:59:01'),
125	(82,NULL,'In CTN practice the follow-up of an AE or a serious adverse event (SAE) unrelated to study product can be considered complete in the following situations EXCEPT:','The event has resolved with or without sequelae.','30 days have elapsed since the participant completed the study.','The event has been downgraded to grade 1.','The event has stabilized with no further change expected.','Conclusion of the study.','','',3,0.00,'2014-10-02 10:59:01'),
126	(83,NULL,'For participants discontinuing participation in a study because of a serious adverse event (SAE) which of the following is INCORRECT:','The SAE should be marked as resolved on the date of discontinued participation since the participant may not be evaluated again in the future.','There should be an attempt to complete any final evaluations required by the study protocol.','There should be an attempt to perform other medical evaluations to try to determine the cause of the SAE and its possible relationship to the study intervention.','There should be an attempt to follow up the outcome of the pregnancy to term in cases of women discontinuing because of pregnancy.','All the above are correct.','','',1,0.00,'2014-10-02 10:59:01'),
127	(84,NULL,'Regarding the goal of data and safety monitoring which of the following is INCORRECT: ','Ensure that risks of participation in a clinical study are minimized as far as is reasonably possible.','Ensure the integrity of the data collected in a clinical study.','Halt a study if safety concerns arise.','Ensure that efficacy endpoints are met.','Preparation of periodic data summary reports to determine if the study should change in any way or be halted.','','',4,0.00,'2014-10-02 10:59:01'),
128	(85,NULL,'Regarding the role of the Data and Safety Monitoring Board (DSMB) which of the following is INCORRECT:','Protect participant safety by being familiar with the study, proposing appropriate analyses, and reviewing outcome and safety data as they become available.','Ensure study integrity by reviewing data on issues such as participant enrollment, site visits, study procedures, completion of forms, data quality, losses to follow-up, and other measures of adherence to the study protocol.','Ensure the study budget is respected.','Monitor adverse events and recommend changes in the protocol or operation of the study if necessary.','All of the above are correct.','','',3,0.00,'2014-10-02 10:59:01'),
129	(86,NULL,'Quality Assurance in clinical trials consists of planned, systematic activities that are conducted to ensure that study data are generated, documented, and reported in compliance with:','The research protocol.','Good Clinical Practice (GCPs) guidelines.','FDA regulations.','All of the above.','','','',4,0.00,'2014-10-02 10:59:18'),
130	(87,NULL,'Quality Assurance is the responsibility of all research team members.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 10:59:18'),
131	(88,NULL,'The main reason site monitoring visits are conducted is to:','Socialize with the research team members.','Ensure compliance with quality standards.','Punish the CTP for making mistakes','All of the above.','','','',2,0.00,'2014-10-02 10:59:18'),
132	(89,NULL,'On-site monitoring activities are conducted:','At study initiation.','At study closeout.','Before, during, and after completion of the study.','On an \"as needed\" basis.','','','',3,0.00,'2014-10-02 10:59:18'),
133	(90,NULL,'The sponsor has the ultimate responsibility for implementing and maintaining Quality Assurance systems. ','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 10:59:18'),
134	(91,NULL,'Common problems identified in audits by the U.S. Food and Drug Administration (FDA) include which of the following:','Inadequate oversight at the Clinical Coordinating Center.','Inadequate records that do not support the reported data.','Inadequate study drug accountability.','A and B','B and C','','',5,0.00,'2014-10-02 10:59:18'),
135	(92,NULL,'Quality data are critical to ensure that the study results are ________.','Stored in the documentation of research sites during the conduct of a study.','Available for participants to review easily when a study is blinded.','Interpreted correctly.','None of the above.','','','',3,0.00,'2014-10-02 10:59:18'),
136	(93,NULL,'When research sites collect incorrect data or do not maintain good documentation practices, what can be a consequence?','Sloppy or incorrect data can lead to misleading conclusions.','Study investigators will increase credibility when publishing results.','Results of studies are interpreted correctly.','All of the above.','','','',1,0.00,'2014-10-02 10:59:18'),
137	(94,NULL,'Who is expected to ensure the highest possible standards of quality are maintained in the conduct of a trial?','Study Investigators.','Research Staff.','Study Monitors.','The Sponsor.','All members of the study team.','','',5,0.00,'2014-10-02 10:59:18'),
138	(95,NULL,'Choose the study document that outlines monitoring procedures for a trial, defining when, how many, and the types of visits to occur.','Study Protocol.','Monitoring Plan.','Manual of Procedures.','Good Clinical Practice (GCP) Guidelines.','','','',2,0.00,'2014-10-02 10:59:18'),
139	(96,NULL,'Study monitors are ________.','Familiar with the product under investigation in the study.','Appropriately trained and have qualifications to monitor clinical studies.','Not required to have any specific knowledge of the trial or the investigational product.','All of the above.','A and B','','',5,0.00,'2014-10-02 10:59:18'),
140	(97,NULL,'Based on Good Clinical Practice (GCP) guidelines, the research site investigator has the primary responsibility for selecting study monitors.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:59:18'),
141	(98,NULL,'Based on Good Clinical Practice (GCP) guidelines, the Sponsor has the primary responsibility for selecting study monitors.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 10:59:18'),
142	(99,NULL,'Protocol Monitor responsibilities are outlined in which ICH GCP guidance?','ICH GCP 5.18.4','ICH GCP 5.2.1','ICH GCP 5.23.3','ICH GCP 5.7','','','',1,0.00,'2014-10-02 10:59:18'),
143	(100,NULL,'Which of the following types of study visits do protocol monitors conduct at research sites?','For Cause','Closeout','Interim','Initiation','B, C, and D','All of the above.','',6,0.00,'2014-10-02 10:59:18'),
144	(101,NULL,'Before a site begins recruitment, a protocol monitor will conduct a visit to review the data the research site has collected from study participants.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:59:18'),
145	(102,NULL,'Site staff may begin recruitment upon completion of all action items required for endorsement, when adequate staff is available and fully trained in their study roles, and after ____.','The research site investigator sends a letter to the sponsor advising of their site-appointed start date.','The research site has been inspected and received approval from an FDA Inspector.','The Lead Investigator and sponsor have provided their approval.','None of the above.','','','',3,0.00,'2014-10-02 10:59:18'),
146	(103,NULL,'Protocol Monitors perform which of the following duties during the conduct of a trial:','Verify the accuracy of reported trial data.','Verify the financial statements of the research site.','Verify that the site has the adequate resources to continue the trial. ','Verify that all research site staff has documentation of driver\'s licensure.','Verify that participant rights and well-being is being protected.','A, C, and E','B, D, and E',6,0.00,'2014-10-02 10:59:18'),
147	(104,NULL,'Once a research site has completed enrollment, protocol monitors do not conduct any additional site visits.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:59:18'),
148	(105,NULL,'The role of monitoring is to support and assist members of the study team to maintain high quality standards.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 10:59:18'),
149	(106,NULL,'Which of the following documents are essential for ensuring that a research study is conducted in a standardized manner:','Research Protocol, Operations Manual, and SOPs.','Contract.','Research Protocol and Operations Manual.','All of the above.','','','',1,0.00,'2014-10-02 10:59:36'),
150	(107,NULL,'Prior to implementation (unless there is an immediate safety concern), a protocol amendment must be approved by:','Food and Drug Administration (FDA).','Institutional Review Board (IRB).','Sponsor.','All of the above.','','','',2,0.00,'2014-10-02 10:59:36'),
151	(108,NULL,'A protocol violation is any action that does not adhere to the study description in the protocol.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 10:59:36'),
152	(109,NULL,'If a protocol violation occurs, it is important that:','The violation is documented.','Measures are taken to prevent re-occurrence.','The violation is reported in accordance with established procedures.','All of the above.','','','',4,0.00,'2014-10-02 10:59:36'),
153	(110,NULL,'A protocol violation is:','An omission (i.e., failure to do something required in the protocol)','An addition (i.e., any action that is not required in the protocol).','A change in any procedure described in the protocol','All of the above.','','','',4,0.00,'2014-10-02 10:59:36'),
154	(111,NULL,'Which of the following refers to a document containing nonclinical and clinical data that describe the previous experience with the experimental intervention, often a medication?','The Research Protocol','The Operations Manual','The Investigator\'s Brochure','The IRB Membership Roster','','','',3,0.00,'2014-10-02 10:59:36'),
155	(112,NULL,'The research protocol describes:','Why the study is being conducted.','What will be done in the study.','Who will be involved in the research study','All of the above','','','',4,0.00,'2014-10-02 10:59:36'),
156	(113,NULL,'Which section of the research protocol should contain the reason for the choice of sample size? ','Statistics','Quality Control and Quality Assurance','Data Management','Study Objectives and Purposes','','','',1,0.00,'2014-10-02 10:59:36'),
157	(114,NULL,'Which section of the research protocol should contain a description of the problem the study is addressing, as well as its public health significance?','Data Management','Background Information','Quality Control and Quality Assurance','Treatment of Subjects','','','',2,0.00,'2014-10-02 10:59:36'),
158	(115,NULL,'Which section of the research protocol should contain a description of the type and duration of follow-up of participants who experience adverse events?','Assessment of Efficacy','Assessment of Safety','Background Information','Study Objectives and Purposes','','','',2,0.00,'2014-10-02 10:59:36'),
159	(116,NULL,'Which section of the research protocol should contain the procedures for recording and reporting adverse events?','Data Management','Selection and Withdrawal of Participants','Assessment of Safety','Background Information','','','',3,0.00,'2014-10-02 10:59:36'),
160	(117,NULL,'Which section of the research protocol should describe the measures that will be taken to avoid or minimize bias (e.g., randomization, blinding)','Treatment of Subjects','Study Objectives and Purposes','Assessment of Efficacy','Study Design','','','',4,0.00,'2014-10-02 10:59:36'),
161	(118,NULL,'Which of the following would you NOT expect to find in the Study Design section of the research protocol?','A description of primary and secondary endpoints.','A schematic diagram of the study design.','The methods for recording and analyzing the effectiveness criteria.','The expected duration of participant participation.','','','',3,0.00,'2014-10-02 10:59:36'),
162	(119,NULL,'Which of the following would you NOT expect to find in the Treatment of Subjects section of the research protocol?','The names of all medications to be administered.','The dosing schedules of all medications to be administered.','Procedures for assessing treatment adherence.','Procedures for accounting for missing, unused, and false data.','','','',4,0.00,'2014-10-02 10:59:36'),
163	(120,NULL,'Which of the following would NOT be a good example of a protocol violation? ','The Research Coordinator has consistently arrived late to study visits.','Only participants over 30 years old have been given the study remuneration described in the protocol.','Two participants were enrolled in the study although they do not meet the inclusion criteria.','A CBC blood specimen is collected before the participant has signed an Informed Consent form.','','','',1,0.00,'2014-10-02 10:59:36'),
164	(121,NULL,'What can be done to try to reduce the number of protocol violations? ','Provide thorough protocol trainings and refreshers.','Notify all staff members of protocol amendments.','Update the Operations Manual to reflect the changes to the protocol.','All of the above.','','','',4,0.00,'2014-10-02 10:59:36'),
165	(122,NULL,'The research protocol must be approved by a designated Institutional Review Board:','Before the research study can begin.','After the first participant is randomized.','By the last participant has completed the last follow up visit.','There is no designated time for approval.','','','',1,0.00,'2014-10-02 10:59:36'),
166	(123,NULL,'Which of the following is NOT an appropriate response to a protocol violation occurrence:','Document the violation and corrective action.','Report the violation to the affiliated IRB.','Reduce the study sample size in order to minimize future protocol violations.','Immediately address any concerns regarding participant safety related to the violation.','','','',3,0.00,'2014-10-02 10:59:36'),
167	(124,NULL,'Which section of the research protocol should describe the pharmacological treatment and any other interventions included in the study?','Treatment of Subjects','Data Management','Selection and Withdrawal of Participants','Assessment of Safety','','','',1,0.00,'2014-10-02 10:59:36'),
168	(125,NULL,'Which section of the research protocol should describe the type and timing of data to be collected for participants who withdraw from the study?','Data Management','Selection and Withdrawal of Participants','Assessment of Safety','Background Information','','','',2,0.00,'2014-10-02 10:59:36'),
169	(126,NULL,'The Investigator should only record observations and other data he/she feels is important to the study.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:59:53'),
170	(127,NULL,'Which is the correct order of shortest record storage requirement to longest storage requirement?','HIPAA, CTN, FDA','CTN, HIPAA, FDA','FDA, HIPAA, CTN','FDA, CTN, HIPAA','CTN, FDA, HIPAA','','',4,0.00,'2014-10-02 10:59:53'),
171	(128,NULL,'One (1) bottle of study medication containing 100 tablets was supplied to the research center. 55 tablets were ingested and 3 tablets were lost. How much study medication is on hand? ','42 tablets.','45 tablets.','97 tablets.','Amount unknown.','','','',1,0.00,'2014-10-02 10:59:53'),
172	(129,NULL,'The Case Report Form (CRF) is treated as a source document if data is directly entered onto the document.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 10:59:53'),
173	(130,NULL,'How long does the FDA require storage of trial-related records?','2 years','5 years','3 years','18 months','','','',1,0.00,'2014-10-02 10:59:53'),
174	(131,NULL,'Source documents are records created during a trial for data collection and can be related to participants medical treatment and history.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 10:59:53'),
175	(132,NULL,'Source documents may include which of the following:','Participant appointment diaries.','Informed consent forms signed by participants.','Study medication logs.','All of the above.','','','',4,0.00,'2014-10-02 10:59:53'),
176	(133,NULL,'Which guidance document defines essential documents for the conduct of clinical trials?','21 CFR 11.1','ICH GCP 4.8','ICH GCP 8.1','42 CFR 2.12','','','',3,0.00,'2014-10-02 10:59:53'),
177	(134,NULL,'Essential documents collected for research projects may be audited or inspected for GCP compliance by which stakeholder?','Financial audit agencies','Regulatory authorities','Quality Assurance monitors','B and C','','','',4,0.00,'2014-10-02 10:59:53'),
178	(135,NULL,'Choose the federal regulation that outlines the records requirements and retention schedule for all federally funded research projects.','21 CFR 11.12','21 CFR 312.62','21 CFR 54.12','21 CFR 1.11','','','',2,0.00,'2014-10-02 10:59:53'),
179	(136,NULL,'Choose the statement that is true of Case Report Forms (CRFs).','Similar to progress notes, CRFs are never considered source documents according to ICH GCP 1.11.','According to ICH GCP 1.11, CRFs may be printed, optical, or electronic documents, used for the collection of protocol-required information.','All research studies use electronic CRFs.','Investigators are never required to maintain CRFs according to the records retention schedule as defined in 21 CFR 312.62.','','','',2,0.00,'2014-10-02 10:59:53'),
180	(137,NULL,'Certificate of Confidentiality is an important document for an additional level of participant privacy protection; however, it is not an essential document to the CTN.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:59:53'),
181	(138,NULL,'Choose the correct example(s) of source documents in a research project.','Study participant\'s state issued driver\'s  license.','Participant diagnostic test results.','Participant\'s AARP card.','A and C.','','','',2,0.00,'2014-10-02 10:59:53'),
182	(139,NULL,'Select the types of progress notes used in research trials.','Clinical notes.','Research notes.','Practitioner-to-Nurse conversation transcripts.','Protocol change history notes.','A and B.','','',5,0.00,'2014-10-02 10:59:53'),
183	(140,NULL,'Study drug accountability is not as important in research projects and investigators do not need to maintain accurate records of study drug disposition.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 10:59:53'),
184	(141,NULL,'When accounting for investigational drugs, investigators record all of the following except:','Amount of drug received at the research site.','Amount of drug used at the research site.','Amount of drug dispensed to non-study participants at the research site.','Amount of drug on hand at the research site.','','','',3,0.00,'2014-10-02 10:59:53'),
185	(142,NULL,'CTN-sponsored studies are required to maintain study records for how long?','18 months','2 years','3 years','5 years','','','',3,0.00,'2014-10-02 10:59:53'),
186	(143,NULL,'According to regulations, every aspect of a research study must be documented in compliance with GCP guidelines in order to obtain useful data.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 10:59:53'),
187	(144,NULL,'Essential documents defined in ICH GCP 8.1 fulfill all of the following purposes <em>except:</em>','Ensure that the primary outcome of the study should have positive results.','Assist in the documentation management for a research trial.','Provide quality assurance auditors and regulatory inspectors with an audit trail for assessing the validity in the conduct of a study.','Verify compliance to GCP, sponsor, and regulatory requirements.','','','',1,0.00,'2014-10-02 10:59:53'),
188	(145,NULL,'Within the CTN, behavioral studies may have requirements for essential documents that differ from or are in addition to GCP guidelines, and may include which of the following:','Counseling materials and manuals.','Audio recordings of behavioral intervention.','Video media files of treatment sessions.','A, B, and C.','','','',4,0.00,'2014-10-02 10:59:53'),
189	(146,NULL,'Choose  the definition for <em>Falsification:</em>','Making up data or results and recording or reporting them.','Changing the research record so that it does not accurately reflect the research findings.','Using another person\'s ideas, processes, results or words without giving credit.','','','','',2,0.00,'2014-10-02 11:00:08'),
190	(147,NULL,'Choose the definition for <em>Plagiarism:</em>','Making up data or results and recording or reporting them.','Changing the research record so that it does not accurately reflect the research findings.','Using another person\'s ideas, processes, results, or words without giving credit.','','','','',3,0.00,'2014-10-02 11:00:08'),
191	(148,NULL,'Choose the definition for <em>Fabrication:</em>','Making up data or results and recording or reporting them.','Changing the research record so that it does not accurately reflect the research findings.','Using another person\'s ideas, processes, results, or words without giving credit.','','','','',1,0.00,'2014-10-02 11:00:08'),
192	(149,NULL,'Which of the following improper activities is viewed as research misconduct:','Financial conflicts of interest.','Misuse of grant funds.','Destruction of the integrity of the research record.','Discrimination.','All of the above.','','',3,0.00,'2014-10-02 11:00:08'),
193	(150,NULL,'The primary responsibility for investigating allegations of research misconduct belongs to:','Office of Research Integrity (ORI)','Researcher(s)','Research institution(s)','B and C.','A, B and C.','','',4,0.00,'2014-10-02 11:00:08'),
194	(151,NULL,'Which of the following does NOT constitute research misconduct according to federal regulations?','Fabrication of data.','Falsification of data.','Failure to protect human research subjects.','Plagiarism.','None of the above.','','',3,0.00,'2014-10-02 11:00:08'),
195	(152,NULL,'To whom does the federal policy on research misconduct apply?','Foundation funded research.','Federally funded research.','Pharmaceutical company funded research.','State funded research.','All of the above.','','',2,0.00,'2014-10-02 11:00:08'),
196	(153,NULL,'Which agency or agencies oversee investigations of alleged research misconduct?','Food and Drug Administration','National Institutes of Health','Office of Research Integrity','Center for Drug Evaluation and Research','All of the above.','','',3,0.00,'2014-10-02 11:00:08'),
197	(154,NULL,'Which of the following does constitute research misconduct according to federal regulations?','Financial conflict of interest.','Misuse of grant funds.','Violation of human subject protections.','Using research data from another researcher without authorization.','All of the above.','','',4,0.00,'2014-10-02 11:00:08'),
198	(155,NULL,'Which element is NOT required for a finding of research misconduct?','Significant departure from accepted practices of the relevant research community.','Research misconduct must be committed \"intentionally, or knowingly, or recklessly.','The misconduct must have resulted in harm to human research subjects.','An allegation of research misconduct must be proven by \"a preponderance of the evidence\" (that is, by most of the evidence).','All of the above are required.','','',3,0.00,'2014-10-02 11:00:08'),
199	(156,NULL,'Researchers and research institutions have the primary responsibility for reporting and investigating allegations of research misconduct.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 11:00:08'),
200	(157,NULL,'Regarding response to an allegation of research misconduct which of the following is INCORRECT:','Those accused of misconduct must be informed of the allegation and of the inquiry.','The accused person(s) must be given a copy of the inquiry report.','The decision to initiate an inquiry must be reported in writing to the Director of the Office of Research Integrity (ORI) within 60 days of its initiation.','If an inquiry provides an adequate basis for an investigation, that investigation should begin within 30 days of completion of the inquiry.','In most cases, the investigation should be completed within 120 days of its start.','','',3,0.00,'2014-10-02 11:00:08'),
201	(158,NULL,'In case of research misconduct in a CTN trial, which of the following is INCORRECT:','The research integrity officer must be contacted immediately when an allegation of research misconduct is made.','The research integrity officer should alert the NIDA Center for the Clinical Trials Network office that an allegation of research misconduct has been made.','Within NIDA, responsibility for oversight of inquiries and investigations into research misconduct rests with the Office of Extramural Affairs.','NIDA must inform the FDA of all research misconduct allegations.','All are correct.','','',4,0.00,'2014-10-02 11:00:08'),
202	(159,NULL,'Regarding response to allegations of research misconduct, which of the following is CORRECT:','The accused researcher is entitled to know who the informant is.','The informant privacy must be protected to the extent possible and may remain anonymous.','The informant may be penalized if the allegations are not sustained even if made in good faith.','Anyone with appropriate expertise may be selected to investigate an allegation of research misconduct.','All cases of alleged misconduct in a clinical trial must be immediately reported to the trial principal investigator, the federal agency sponsoring the trial and the Office of Research Integrity (ORI).','','',1,0.00,'2014-10-02 11:00:08'),
203	(160,NULL,'Regarding penalties for research misconduct which of the following is CORRECT:','Research institutions may penalize researchers found to have committed research misconduct.','The Office of Research Integrity (ORI) may impose penalties of its own on researchers or institutions.','Researcher\'s employment termination is one possible penalty.','Supervision of future research activities may be imposed to the researcher as a penalty.','All of the above.','','',5,0.00,'2014-10-02 11:00:08'),
204	(161,NULL,'Penalties for research misconduct imposed by the Office of Research Integrity (ORI) may include all the following EXCEPT:','Correction of the research records.','Letter of reprimand.','Researcher\'s employment termination.','Suspension or termination of the research grant.','Suspension or debarment from receiving federal funds.','','',3,0.00,'2014-10-02 11:00:08'),
205	(162,NULL,'Which one is NOT a goal of the regulations for dealing with research misconduct (42 CFR 50 subpart A)','To define research misconduct.','To define penalties for research misconduct.','To establish procedures for reporting and investigating research misconduct.','To protect both those who report alleged research misconduct.','To protect those accused of research misconduct.','','',2,0.00,'2014-10-02 11:00:08'),
206	(163,NULL,'Which of the following events is considered research misconduct?','Unintentional errors in data entry.','Differences of opinion.','Failure to protect human research subjects.','Authorship dispute not involving plagiarism.','None of the above.','','',5,0.00,'2014-10-02 11:00:08'),
207	(164,NULL,'The Office of Research Integrity (ORI) responsibilities include all the following EXCEPT:','Determine whether an inquiry provides an adequate basis for an investigation.','Oversee investigations of research misconduct allegations.','Make final decisions on findings of research misconduct.','Provide technical assistance to any institution that is responding to an allegation of research misconduct.','Hold informal discussions with researchers about allegations of research misconduct or the handling of research misconduct cases.','','',1,0.00,'2014-10-02 11:00:08'),
208	(165,NULL,'The responsibilities of individual researchers in regards to research misconduct include all the following EXCEPT:','Maintain a high standard of integrity at all times in all of their research activities.','Assume responsibility for their actions.','Investigate and rule on suspicions or allegations of research misconduct.','Take misconduct or alleged misconduct seriously.','Report apparent misconduct by other researchers.','','',3,0.00,'2014-10-02 11:00:08'),
209	(166,NULL,'An investigation for research misconduct will typically include all the following EXCEPT:','Examining all documents, including relevant research data, proposals, publications, correspondence, and records of telephone calls.','Interviewing all informants and all those accused of misconduct, as well as others who may have information about key aspects of the allegation.','Preparing a report of the investigation\'s findings and making the report available for comment by all informants and all those accused of misconduct.','Notifying of the FDA in cases where the research entails the use of an approved medicinal product or device.','Submitting a final report to the Office of Research Integrity (ORI).','','',4,0.00,'2014-10-02 11:00:08'),
210	(167,NULL,'If the Sponsor transfers all study related duties and functions to a clinical research organization (CRO), the Sponsor is no longer responsible for the conduct of the study.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 11:00:25'),
211	(168,NULL,'The Principal Investigator retains ultimate responsibility for the conduct of the study even if specific tasks are delegated to other staff members.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 11:00:25'),
212	(169,NULL,'Match Lead Investigator with its appropriate description.','Responsible for monitoring the studies within the Node.','Responsible to NIDA for study performance at the Node.','Responsible for study integrity and human subject protection at a CTP.','Responsible for ensuring the care and safety of study participants.','Responsible for the overall conduct of the study.','','',5,0.00,'2014-10-02 11:00:25'),
213	(170,NULL,'The research team at the Community Treatment Program (CTP) may include all of the following, <em>except</em>:','Research Assistants.','Therapists/Counselors.','CTP Principal Investigator.','Protocol Monitor.','Medical/Pharmacy staff.','','',4,0.00,'2014-10-02 11:00:25'),
214	(171,NULL,'Each CTN Node will have an exact number of Protocol PIs, research assistants, quality assurance monitors, node regulatory staff who have all clearly defined work at the node or at the site and will exactly mirror other Nodes across the country.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 11:00:25'),
215	(172,NULL,'The Sponsor may <strong>NOT</strong> do which of the following actions:','Transfer to or share with a CRO most or all regulatory activities, providing core training, and on site data monitoring.','Transfer to a CRO the responsibility for data storage, quality and analysis.','Transfer the ultimate responsibility for quality and integrity of the trial data to a Lead Investigator.','Designate appropriately qualified medical personnel to advise on trial-related medical questions or problems.','','','',3,0.00,'2014-10-02 11:00:25'),
216	(173,NULL,'All study participants should receive appropriate medical care for both study-related adverse events as well as all medical conditions unrelated to study participation.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 11:00:25'),
217	(174,NULL,'The Sponsor is responsible for:','Implementing and maintaining quality assurance and quality control systems.','Ensuring that the study is conducted and documented in compliance with the protocol and GCP.','Ensuring that  the study is conducted and documented in compliance with regulatory requirements.','All of the above.','','','',4,0.00,'2014-10-02 11:00:25'),
218	(175,NULL,'The Sponsor is responsible for designating qualified individuals to carry out all stages of the study process, EXCEPT:','Managing and verifying the study data and planning and conducting the statistical analysis and preparing reports.','Supervising the overall conduct of the study and monitoring study performance.','Releasing data on ClinicalTrials.gov with PHI and identifiers to link back to study participants.','Ensuring the safety and rights of human participants.','Designing the protocol.','','',3,0.00,'2014-10-02 11:00:25'),
219	(176,NULL,'In the conduct of a research study, central roles include which of the following:','Study Physician.','Sponsor.','Principal Investigator.','B and C.','','','',4,0.00,'2014-10-02 11:00:25'),
220	(177,NULL,'Research trials do not require quality assurance and quality control systems as long as the investigators are honest.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 11:00:25'),
221	(178,NULL,'According to ICH GCP 5.3, who is responsible for medical expertise on the study team?','Study Coordinator','Pharmacist','Sponsor-designated qualified medical personnel','Phlebotomist','','','',3,0.00,'2014-10-02 11:00:25'),
222	(179,NULL,'The Sponsor may contract with an organization to handle trial-related responsibilities on behalf of the sponsor should be:','Specified in writing.','Agreed upon verbally but in writing is not required.','Defined in a Transfer of Regulatory Obligations (TORO) or other contractual documentation.','A and C.','','','',4,0.00,'2014-10-02 11:00:25'),
223	(180,NULL,'Based on criteria defined in ICH GCP 5.4 and 5.5, the Sponsor is responsible primarily for study design and management, including each of the following except:','Study report submissions to applicable regulatory authorities.','Verification of data.','Interference in the day-to-day operation of research sites.','Participant safety.','Trial progress and performance.','','',3,0.00,'2014-10-02 11:00:25'),
224	(181,NULL,'A principal investigator is required to comply with the Institutional Review Board (IRB) for:','Reporting protocol deviations or changes collectively once the study is closed.','Beginning a study based on a predetermined timeline by the study team, even if that is prior to IRB approval.','Hiring specific study staff based on social status.','Obtaining initial and continuing review approval at the start and during the course of a research study.','','','',4,0.00,'2014-10-02 11:00:25'),
225	(182,NULL,'Principal Investigators are encouraged, but not required, to conduct research in compliance with the study protocol. Occasionally, they may make adjustments in the protocol as needed for certain participants.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 11:00:25'),
226	(183,NULL,'All study staff is responsible for the following, <em>except</em>:','Assigning study participants to their preferred treatment group in a placebo controlled and blinded investigational drug trial.','Protecting the rights and safety of study participants.','Complying with the study protocol.','Reporting study data accurately and correctly.','','','',1,0.00,'2014-10-02 11:00:25'),
227	(184,NULL,'In CTN research studies, the Node Principal Investigator and the Protocol Principal Investigator have the same responsibilities.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 11:00:25'),
228	(185,NULL,'Research assistants are responsible for which kinds of responsibilities in CTN research trials?','Study performance at the research site.','Conducting physical examinations.','Ensuring that study data are accurately collected and reported.','Maintaining regulatory files at the study site.','A and D.','C and D.','',6,0.00,'2014-10-02 11:00:25'),
229	(186,NULL,'What agency is the Sponsor responsible for studies conducted in the CTN?','NHLBI','OHRP','NIAID','NIDA','FDA','','',4,0.00,'2014-10-02 11:00:25'),
230	(187,NULL,'A successful recruitment plan includes all the following elements <em>except</em>:','Avoiding unnecessarily restrictive inclusion and exclusion criteria in the protocol.','Identifying a recruiting strategy during protocol development.','Generously compensating participants for their time and expenses.','None of the above.','','','',3,0.00,'2014-10-02 11:00:38'),
231	(188,NULL,'Investigators/Researchers must ensure that subjects identified for participation in a study are not selected because of their:','Availability.','Social status.','Vulnerability.','All of the above.','','','',4,0.00,'2014-10-02 11:00:38'),
232	(189,NULL,'A potential study participant must meet all protocol specified exclusion criteria in order to be excluded from participation in the study.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 11:00:38'),
233	(190,NULL,'Study participant recruitment cannot begin until the IRB has approved the:','Informed Consent form.','Protocol.','Advertisements.','All of the above.','','','',4,0.00,'2014-10-02 11:00:38'),
234	(191,NULL,'The IRB reviews and approves incentives for participation for all of the following points <em>except</em>:','Monetary value.','Form.','Creativity.','Conditions of award.','','','',3,0.00,'2014-10-02 11:00:38'),
235	(192,NULL,'In order for a clinical investigation of a research question to occur, research sites must fulfill which of the following goals?','Improve an investigator\'s prominence in a field of study.','Increase the popularity of a research site.','Recruit an adequate number of appropriate participants.','Retain study participation numbers for the time period specified in the research protocol.','A and C','C and D','',6,0.00,'2014-10-02 11:00:38'),
236	(193,NULL,'Which agency must approve recruitment and retention materials for any federally funded research prior to utilization in a clinical study?','Administrative Research Board','Institutional Review Board','International Conference on Harmonisation','Executive Committee for the CTN','','','',2,0.00,'2014-10-02 11:00:38'),
237	(194,NULL,'There are two major elements involved in recruitment:<ul><li>Defining the right study population; and</li><li>Recruiting participants appropriately and ethically.</li></ul>','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 11:00:38'),
238	(195,NULL,'Issues of consideration for study population and recruitment include all of the following <em>except</em>:','Fairness','Social status','Vulnerable populations','Inclusion criteria','Exclusion criteria','','',2,0.00,'2014-10-02 11:00:38'),
239	(196,NULL,'Inclusion and exclusion criteria are defined in the study protocol.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 11:00:38'),
240	(197,NULL,'Vulnerable populations in clinical studies include which of the following?','Children','Mentally disabled','Pregnant women','Men','A, B, and C','A, B, and D','',5,0.00,'2014-10-02 11:00:38'),
241	(198,NULL,'The National Institutes of Health never approves clinical studies that exclude all women or minorities from participation.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 11:00:38'),
242	(199,NULL,'The Belmont Report of 1979 established which key principals of human research protections:','Respect, justice, and honor.','Justice, search for truth, and respect.','Honor, humanity, and cause no harm.','Respect for persons, beneficence, and justice.','','','',4,0.00,'2014-10-02 11:00:38'),
243	(200,NULL,'It is important that findings from a clinical study be relevant to people who were not in the study but have the same characteristics as the study participants.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 11:00:38'),
244	(201,NULL,'It is a best practice in clinical research to establish highly stringent inclusion and exclusion criteria.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 11:00:38'),
245	(202,NULL,'Which agency has issued guidelines for clinical studies involving alcohol-abusing participants?','National Advisory Council on Alcohol Abuse and Alcoholism','Research Board for Substance Abuse','Scientific Advisory Board for Alcohol and Substance Use Dependence','Research Council for Substance Use and Alcohol Addiction','','','',1,0.00,'2014-10-02 11:00:38'),
246	(203,NULL,'Success factors for clinical study retention include all of the following <em>except</em>:','Identifying and overcoming barriers to retention.','Identifying and resolving problems in a timely manner.','Giving participants substantial monetary compensation contingent upon their completion of the entire study.','Treating the participant with respect.','','','',3,0.00,'2014-10-02 11:00:38'),
247	(204,NULL,'If a study participant indicates that he plans to move from one residence to another during study participation, site staff should ___________.','Wait for the participant to move and hope to get the new contact information during a later study visit.','Record the new contact information in the participant\'s file and advise the site\'s research team.','Keep sending notifications to the participant\'s former address after the move date.','Do nothing.','','','',2,0.00,'2014-10-02 11:00:38'),
248	(205,NULL,'Study teams may use incentives for study participation; however, careful consideration should be given to avoid ___________.','Inducement','Rewards','Coercion','Free medical care','A and C','B and D','',5,0.00,'2014-10-02 11:00:38'),
249	(206,NULL,'The FDA has strict guidelines on the exact dollar amount of money to offer study participants enrolled in a clinical investigation; therefore, this amount is not required for inclusion in the study\'s Informed Consent document.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 11:00:38'),
250	(207,NULL,'The Code of Federal Regulations (CFR) defines an investigational new drug as:','<em>No</em> substance seeking FDA approval.','Any substance (such as, a drug, vaccine or biological product) for which FDA approval is being sought.','Generic of a branded drug.','All of the above.','','','',2,0.00,'2014-10-02 11:00:52'),
251	(208,NULL,'The sponsor must wait _____ calendar days before initiating research activities in support of an Investigational New Drug application (IND).','7','15','30','60','','','',3,0.00,'2014-10-02 11:00:52'),
252	(209,NULL,'The investigational new drug regulations are in full effect during the conduct of a behavioral research study.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 11:00:52'),
253	(210,NULL,'A drug has been on the market for a long time as a treatment for migraine, but has been used by some doctors to treat depression in children.  An IND, therefore, is not needed to conduct a clinical trial using this drug, which is supplied by the manufacturer free of charge for use in the treatment of childhood depression.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 11:00:52'),
254	(211,NULL,'An approved drug can be used in a clinical trial without any changes to the label or packaging.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 11:00:52'),
255	(212,NULL,'Use of a lawfully marketed drug for an unapproved use in the course of medical practice is not a clinical investigation and does not require an IND because it involves the use in an individual patient where the primary intent is to treat the patient.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 11:00:52'),
256	(213,NULL,'If a drug has never been tested in humans before and the goal of the initial study is to establish the safety and pharmacokinetics of a single ascending dose in healthy subjects, this study is considered a _____ study.','Phase 1','Phase 2','Phase 3','Phase 4','','','',1,0.00,'2014-10-02 11:00:52'),
257	(214,NULL,'A study conducted in a small number of participants, with a specific disease and investigating a number of doses of a drug to assess safety, is usually considered a _______ study.','Phase 1','Phase 2','Phase 3','Phase 4','','','',2,0.00,'2014-10-02 11:00:52'),
258	(215,NULL,'A clinical trial powered to show the efficacy of a drug in a specific disease population, with the goal of using these data as part of a marketing application, is usually considered a _____ study','Phase 1','Phase 2','Phase 3','Phase 4','','','',3,0.00,'2014-10-02 11:00:52'),
259	(216,NULL,'After a drug has been approved for marketing, FDA may ask the company selling the drug to continue to examine the safety of the drug when used long term.  These studies are usually considered _____ studies.','Phase 1','Phase 2','Phase 3','Phase 4','','','',4,0.00,'2014-10-02 11:00:52'),
260	(217,NULL,'The holder of the IND application, usually the company, institution or investigator who submitted the application is called the _____ of the IND.','Sponsor','Principal Investigator','Investigator','Responsible party','','','',1,0.00,'2014-10-02 11:00:52'),
261	(218,NULL,'To obtain a notice of exemption of IND requirements from FDA for a particular clinical study, the sponsor of the potential IND should:','Submit the IND application and wait 30 days for FDA review.','Submit a notice to FDA that the study is IND exempt and then start the study.','Submit the protocol to the IRB for review.','Submit Form FDA1572 to FDA.','','','',1,0.00,'2014-10-02 11:00:52'),
262	(219,NULL,'If a protocol change is needed to eliminate an apparent immediate hazard to study participants, this should only be implemented after:','Notifying the FDA via a protocol amendment.','Notifying the IRB.','A and B.','A change to eliminate an apparent immediate hazard should be implemented immediately.','','','',4,0.00,'2014-10-02 11:00:52'),
263	(220,NULL,'An unexpected death of a subject while participating in a clinical trial which is considered possibly related to the drug being tested should be reported to FDA:','As soon as possible but no later than 7 days after notification of the event.','As soon as possible but no later than 15 days after notification of the event.','In the annual report.','In the final study report.','','','',1,0.00,'2014-10-02 11:00:52'),
264	(221,NULL,'A Sponsor of a clinical trial is responsible for many aspects of clinical trial conduct, which includes:','Maintaining the clinical trial master file.','Supplying and disposing of Investigational Drug.','Ensuring the Investigators are conducting the trial according to the protocol.','A, B, and C.','','','',4,0.00,'2014-10-02 11:00:52'),
265	(222,NULL,'An Investigator participating in a clinical trial is responsible for protecting the rights, safety, and welfare of trial participants. Part of this responsibility is:','Ensuring all subjects are consented appropriately and documented using the IRB approved Informed Consent form.','Making sure that target enrollment goals are met.','Enrolling subjects into the study who meet the exclusion criteria.','Ensuring that the names of all subjects participating in the study are available to the general public.','','','',1,0.00,'2014-10-02 11:00:52'),
266	(223,NULL,'If a study is exempt from IND requirements, then an IRB does not have to be involved at any point during study conduct.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 11:00:52'),
267	(224,NULL,'Behavioral studies involving patients taking approved drugs may, in some cases, be exempt from the requirements to submit an IND.','TRUE','FALSE','','','','','',1,0.00,'2014-10-02 11:00:52'),
268	(225,NULL,'If a study is exempt from IND requirements, then monitoring of the safety of participants on the study is not required.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 11:00:52'),
269	(226,NULL,'An investigational drug cannot be a controlled substance as it is not yet approved for sale.','TRUE','FALSE','','','','','',2,0.00,'2014-10-02 11:00:52');
270
271/*!40000 ALTER TABLE `gcp_questions` ENABLE KEYS */;
272UNLOCK TABLES;
273
274-- Drop old questions_sections table
275DROP TABLE IF EXISTS `gcp_questions_sections`;
276
277-- Create new question_sections table
278CREATE TABLE `gcp_questions_sections` (
279  `ID` int(11) NOT NULL AUTO_INCREMENT,
280  `ID_QUESTION` int(11) DEFAULT NULL,
281  `ID_SECTION` int(11) DEFAULT NULL,
282  `created_at` timestamp NULL DEFAULT CURRENT_TIMESTAMP,
283  PRIMARY KEY (`ID`),
284  KEY `ID_QUESTION` (`ID_QUESTION`),
285  KEY `ID_SECTION` (`ID_SECTION`)
286) ENGINE=MyISAM DEFAULT CHARSET=latin1;
287
288LOCK TABLES `gcp_questions_sections` WRITE;
289/*!40000 ALTER TABLE `gcp_questions_sections` DISABLE KEYS */;
290
291-- Associate new questions with the appropriate sections
292INSERT INTO `gcp_questions_sections` (`ID`, `ID_QUESTION`, `ID_SECTION`, `created_at`)
293VALUES
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473	(180,180,9,'2014-10-02 11:00:31'),
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478	(185,185,9,'2014-10-02 11:00:31'),
479	(186,186,9,'2014-10-02 11:00:31'),
480	(187,187,10,'2014-10-02 11:00:45'),
481	(188,188,10,'2014-10-02 11:00:45'),
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507	(214,214,11,'2014-10-02 11:00:58'),
508	(215,215,11,'2014-10-02 11:00:58'),
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510	(217,217,11,'2014-10-02 11:00:58'),
511	(218,218,11,'2014-10-02 11:00:58'),
512	(219,219,11,'2014-10-02 11:00:58'),
513	(220,220,11,'2014-10-02 11:00:58'),
514	(221,221,11,'2014-10-02 11:00:58'),
515	(222,222,11,'2014-10-02 11:00:58'),
516	(223,223,11,'2014-10-02 11:00:58'),
517	(224,224,11,'2014-10-02 11:00:58'),
518	(225,225,11,'2014-10-02 11:00:58'),
519	(226,226,11,'2014-10-02 11:00:58');
520
521/*!40000 ALTER TABLE `gcp_questions_sections` ENABLE KEYS */;
522UNLOCK TABLES;
523
524
525-- 01/08/2015 - Fix 100 users who have a score of zero but a filled-in completion date.
526-- STAGING: X (01/08/2015)
527-- QA: X (01/08/2015)
528-- PRODUCTION: X (01/08/2015)
529UPDATE gcp_users_courses SET date_comp = null WHERE date_comp != '0000-00-00 00:00:00' AND score < '80';