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1. The primary purpose for IRB/IEC approval of posters, fliers, social media posts, and promotional items is to:
A) Assure the ads do not impinge on confidentiality agreements.
B) Safeguard the rights, safety, and well-being of all potential subjects.
C) Review the content for ethically or morally sensitive issues.
D) Confirm subjects receive the appropriate reimbursement.
2. Who ensures information regarding payments to subjects is documented in a written consent form?
A) Sponsor
B) Coordinator
C) PI
D) IRB/IEC
3. Who on the local site research study team is accountable for the unblinding documentation of IP?
A) Pharmacist
B) CRC
C) PI
D) Regulatory manager
4. Which strategy is used to safeguard subject privacy?
A) Conduct subject-related conversations in controlled environments.
B) Utilize subject initials on correspondence.
C) Email updated enrollment logs to the CRA.
D) Store source documentation in the CRC's office.
5. Who is responsible for securing agreement from all involved parties to ensure direct access of all trial-related source documents?
A) Sponsor
B) CRC
C) CRO
D) Investigator
Solutions:
| Question # 1 Answer: B | Question # 2 Answer: D | Question # 3 Answer: C | Question # 4 Answer: A | Question # 5 Answer: A |
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