Gp Task 1:

Roles and Responsibilities of IEC members

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1. The Chairperson of the IEC is appointed by

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1. Other IEC members
2. Head of the Institute
3. Secretary of the IEC
4. Head of the research dept. of the institute

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Key: B

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2. Which of the following can serve as lay member of the IEC?

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1. Clerk of the institute
2. Literate housewife
3. Any patient attending the hospital
4. Physiotherapist of some other institute

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Key:B

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3. Dr. ABC is the Chairperson of the IEC and is planning to go to the USA on long leave. In that case,

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1. The Member Secretary performs all the functions of the Chairperson
2. This Chairperson is disqualified and a new chairperson elected in the next meeting
3. The present Chairperson will nominate a committee member as Acting Chairperson
4. Head of Institute acts as Chairperson

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Key: C

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4. During the IEC meeting, ALL of the following are functions of the Chairperson EXCEPT

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1. Appoint the Member Secretary
2. Ensure that contributions of the non-technical members to the meeting are adequate
3. Ensure that members declare conflict of interest and these are handled appropriately prior to the meeting
4. Resolve a contentious issue by vote (or as per SOP)

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Key: A

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5. The legal expert in the IEC primarily reviews the following documents of any research proposal

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1. Protocol, CRF, patient diary
2. Insurance Policy, CTA, MOU
3. Advertisement for recruitment, patient reminder card, IB
4. Site profile, PI qualifications, Investigator Brochure

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Key: B

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6. The lay person in the IEC primarily reviews the following documents of any research proposal

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1. Protocol, CRF
2. Investigator Brochure
3. Patient Information Sheet and ICF
4. Biodata of the Clinical Trial team members

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Key: C

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7. ALL of the following are the activities of the administrative staff of the Secretariat EXCEPT

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1. Circulate the research proposals to all members
2. Assist in preparing the agenda and the minutes
3. Review the documents prior to the meeting
4. Check for completeness of the documents

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Key: C

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8. The Member Secretary of the IEC is

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1. An internal member belonging to the institute
2. Elected among the EC members
3. Devoid of any voting rights over a proposal
4. Cannot be the Principal Investigator of a project during his/her tenure

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Key: A

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9. ALL of the following can fulfill the role of a social scientist in the IEC EXCEPT

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1. Representative of an NGO
2. Social worker
3. Professor of Social Sciences
4. Any individual who undergoes a certified course in philosophy

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Key: D

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10. A Clinical trial can be monitored on behalf of the IEC by

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1. Any IEC member
2. IEC Secretariat
3. Chairperson
4. Head of the Institute

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Key: A

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11. All members of an IEC are usually appointed by the�

1. Chairperson of the IEC
2. DCGI office
3. Head of the Institute
4. Secretary of the Research dept. of the institute

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Key: C

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12. After receipt of the appointment letter, every member needs to submit the following documents for EC records prior to the first meeting

1. Acceptance letter, signed current CV
2. GCP training certificate
3. Recent CV
4. Research methodology training certificate

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Key: A

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13. Conflict of interest (COI) is declared by all members at

1. The initiation of their tenure
2. At the beginning of every IEC meeting
3. The beginning of the tenure and at the beginning of each IEC meeting in which projects are to be reviewed for which he/she has COI
4. Every 6 monthly intervals

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Key: C

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14. In a particular IEC meeting if the “lay person” is absent, then

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1. As quorum is not met the meeting has to be cancelled on that date
2. Meeting can be conducted
3. Meeting can be conducted however minutes are to be additionally approved by the lay person
4. Another lay person is appointed immediately to the committee and attends the meeting with permission of the chair

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ANSWER: A

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15. The IEC Secretariat receives an SMS just before the IEC meeting that the legal expert is unable to attend the meeting. The Member Secretary then

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1. Reschedules the meeting
2. Requests the clinician member to be legal expert as he also has an LLB degree
3. Requests one of the non medical member to act as legal expert
4. Requests a member from the legal department of the institute to attend meeting as he had good knowledge of Indian laws

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Key: A

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16. The minutes of IEC meeting are prepared by

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1. Chairperson
2. Any member
3. Member Secretary
4. Administrative staff of EC

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Key: C

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17. Minutes of an IEC meeting are approved by

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1. Chairperson only
2. All members on email
3. All members in the subsequent IEC meeting
4. Legal expert

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Key: C

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18. Final project approval letters which are sent to the Principal Investigator are signed by the

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1. Chairperson and Member Secretary
2. Member Secretary
3. Chairperson
4. Authorized signatory as per the SOP of the IEC

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Key: D

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19. In a particular IEC meeting, a project on radiofrequency ablation in arrhythmia (the IEC has no medical expertise in this area) is being reviewed

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1. The IEC returns the project back to the investigator stating it cannot review the project as it has no expertise
2. The IEC sends the project to an arrhythmia specialist(an external expert, empanelled as per SOP) for review
3. IEC feels that even if they do not understand the scientific aspects then can and should review the ethics aspect and grant approval
4. The IEC inducts an arrhythmia specialist as its member and reviews the project in the next meeting

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Key: B

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20. The primary reviewer / lead discussant for a given project review are decided by the

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1. The whole IEC
2. Member Secretary
3. Chairperson
4. Administrative staff on random basis

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Key: A

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21. The non medical members of an IEC are NOT expected to review

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1. Project progress reports
2. SAE reports
3. Minutes of the meeting
4. Agenda of the meeting

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Key: B

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22. The non –medical, non-scientific members can perform ALL the following activities EXCEPT

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1. Conduct trial site monitoring
2. Decision making for compensation in trial related injury
3. Scientific review of a project
4. Undergo GCP training

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Key: C

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23.The type of review that a project submitted to the IEC would undergo [i.e. full-board, expedited or exemption from review] is decided by

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1. The PI submitting the project
2. The IEC Secretariat depending on the study design
3. All IEC members
4. Criteria set in the SOP

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Key: D

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24. The Confidentiality agreement is signed by ALL members of

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1. The IEC
2. The IEC and the administrative staff
3. The IEC, administrative staff and experts to whom projects are sent for expert opinion
4. The IEC, administrative staff and Head of the Institute

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Key: C

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25. Knowledge of changing regulations regarding trials involving new drugs is required by

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1. Legal expert of the IEC and Member Secretary
2. Lay person
3. Chairperson
4. Secretariat

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Key: A

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26. Alternate IEC members are

1. Back up for ANY member who is absent for the meeting
2. Pre-appointed for a given tenure as a back up for a specific regular member for a meeting
3. Not supposed to review any documents
4. Will be not allowed to vote

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Key: B

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27. Project query letters are signed by

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1. Member Secretary
2. Any IEC member
3. Administrative officer of the IEC
4. Chairperson

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Key:A

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28. The minutes of the meeting will contain all of the following EXCEPT

1. Names of the members attended
2. Protocol summary of each project reviewed
3. Type of decision making –consensus or voting
4. Names of members declaring COI

Key: B

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29. If a member is unable to attend an IEC meeting he/she must

1. Inform the secretariat à priori
2. Submit a leave application in the previous meeting
3. Be disqualified from that EC
4. Sign the attendance register when he attends subsequent meeting and not declare his absenteeism

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Key: A

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30. If the Member Secretary has declared COI for a particular project in a given EC meeting, then during that project review

1. He / she refrains from being the Member Secretary for that meeting
2. Any other internal member serves as acting Member Secretary for that part of the meeting when this project is being discussed and the MS steps out
3. She/he can continue to be the Member Secretary for the meeting and note the CoI in the minutes
4. She/ he can continue to be the Member Secretary but does not vote

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Key: B

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31. Which of the following has the IEC to primarily check for in a clinical trial liability policy:

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1. The insurance company issuing the policy
2. Coverage of the clinical trial under the policy
3. Geographical coverage of various clinical trial sites.
4. Mode of settlement of a claim under the policy. 

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Key: B

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32. If a new member is inducted in an IEC it is preferred that he / she

1. Undergoes SOP and GCP training prior to attending any meeting
2. Attends IEC meetings as observer for a while
3. Starts reviewing projects and later attends the meeting
4. Attends meetings of other IECs to gather the experience

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Key: B

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33. The social worker on the IEC while reviewing the project looks at the

1. Ethical issues
2. Scientific lacunae
3. Social and cultural aspects
4. Risks of the intervention

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Key: C

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34. In an IEC meeting if non medical members are not participating in the deliberations of the meeting then,

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1. Medical members should stop deliberating
2. Chairperson must request opinion of non medical members on the deliberations
3. Secretary minutes that all non medical members had no queries
4. Medical members deliberate and decisions are taken about the protocol

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Key: B

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35. Mr. ABC wants to attend the IEC meeting of XYZ institute as an observer because he is researching “Ethical conduct of clinical trials in India”. For this

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1. He has to take prior permission of the Chairperson to attend the meeting
2. He can attend after declaring conflicts of interest
3. Head of Institute sends him to the IEC with instructions to Member Secretary to permit him to attend
4. He cannot attend as external guest

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Key: A

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36. In an IEC meeting a bioequivalence project is being reviewed, in which there are 12 blood collections in 24 hours. The lay-person feels this is unethical.

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1. The project cannot be approved
2. Chairperson and medical IEC members need to examine and explain to the lay person about the scientific need, as well as the benefit risk assessment, and the risk minimization plans
3. Immediately call the investigator to explain
4. Request to decrease the number of blood collections

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Key: B

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37. ALL of the following are functions of the Member Secretary EXCEPT

1. Ensure that quorum is complete and then initiate the meeting
2. Preparation of minutes
3. Circulation of the projects for review to all members
4. Prepare query letters for projects

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Key: A

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38. The composition of every IEC �

1. Is multidisciplinary and multi-sectorial
2. Has equal gender representation
3. Has equal internal and external members
4. Has equal medical and non medical members

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Key: A

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41. If an IEC decides to form a SAE sub committee then the preferred members will be

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1. Pharmacologist, clinician and legal expert
2. Legal expert and clinician
3. Pharmacologist, legal expert and lay person
4. Any three internal members

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Key: A

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42. If an IEC faces an inquiry committee then,

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1. Chairperson has to represent the IEC
2. Chairperson and Member Secretary have to represent the IEC
3. Any member can represent on behalf of EC
4. Member Secretary has to answer.

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Key: B

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