Sponsor's roles/responsibilities

Question 1

Before an investigator can begin a study, the sponsor shall obtain the following items:

Part 312

Answer 1

1) Form 1572
2) Investigator CV
3) Clinical protocol (standard of practice)
4) Form 3455 or 3454 (FDF)

Question 2

Crucial components in Form 1572:

Answer 2

1) IND numbers to be conducted by investigator
2) Name and address of IRB responsible for review/approval of studies
3) Site location
4) Commitment by investigator to conduct study according to relevant regulations

Question 3

What are 10 crucial responsibilities of a sponsor?

Answer 3

-Study design and planning
-Funding and resources
-Site selection and management (provide training)
-Monitoring and oversight
-Safety management
-Data management and analysis
-Compliance and quality assurance
-Reporting to regulatory bodies, IRB/IEC, and stakeholders.
-Participant welfare through examining ICF prior to study procedures in the context of strict ethical consideration.
-Publication and dissemination

Question 4

Who submits the investigator brochure (IB) to the IRB and who keeps it up to date?

Answer 4

Sponsor

Question 5

What the hell is the point of monitoring ?

Answer 5

1) Ensure rights and well-being of human subjects are protected.
2) Ensure reported data are accurate, complete, and VERIFIABLE via source docs.
3) Trial is conducted in compliance with protocol, GCP, and regulatory requirements.

Question 6

True or False: According to the ICH GCP, The investigator should develop a systematic, prioritized, risk-based approach to monitoring clinical trials.

Answer 6

F; sponsor dictates this.

Question 7

What is centralized monitoring?

Answer 7

Sponsor provides remote monitoring of a site with a team of trained persons (e.g., data managers, and etc).

Question 8

What should a sponsor verify during an on-site visit?

Answer 8

-Storage times/conditions of investigational product (IP)
-Study products are delivered to appropriate subjects
-Subjects are provided with sufficient education on use/storage, and handling
-Receipt, use and return of IP is controlled and documented.
-Disposition of unused IP is acceptable.

Question 9

What are 5 biggest priorities for monitors to verify in relation to CRFs?

Answer 9

-Data is reported accurately and consistent with source with GCP.
-Any dose/therapy modifications are documented.
-AE, concomitant meds, and etc are reported accordingly.
-Missed visits, absence of tests/exams despite its necessity per CRF.
-Withdrawals & lost to follow-up of enrolled subjects are reported and explained.

Question 10

T/F: Per ICH GCP, monitoring report is OPTIONAL after each visit or trial-related commuication.

Answer 10

F

Question 11

What is included in a monitoring report? (7)

Answer 11

-Visit details (Date/Site info/staff involved)
-Purpose (routine, SIV, close-out visit)
-Study progress (endpoint efficacy, enrollment targets, and etc.)
-Findings and action items (missed PD, AE, queries, and etc.
-Verification of data consistency and accuracy between CRF and source.
-Site-communications, decisions made during the visit
-Signatures and approvals

Question 12

What is a monitoring plan?

Answer 12

A document that serves as a roadmap for monitoring activities and defines how the trial’s progress and data integrity will be managed. It protects trial integrity and ensures patient safety through a systematic method of promptly identifying possible issues.

Question 13

What is an audit

Answer 13

systematic, independent examination of a trial to ensure compliance with regulations, protocols, and standards. It is to assess the accuracy, completeness, and reliability of the data and to verify that the trial was conducted in accordance with GCP, regulatory requirements, and the study protocol.

Question 14

Who determines the proper storage temperature, condition, time and procedures for the investigational product?

Answer 14

Sponsor

Question 15

How long will sponsor maintain records showing shipment, receipt of test articles (including names of investigators/sites)

Answer 15

2 years

Question 16

When a site is non-compliant the sponsor will either secure compliance or discontinue shipments and end sites involvement with the study according to what form?

Answer 16

1572

Question 17

Which regulatory document is required to be maintained by the sponsor to ensure the study compliance with GCP?

Answer 17

Trial Master File

Question 18

When is a Data Safety Monitoring Plan (DSMP) typically required?

a) For every clinical trial regardless of risk
b) Only for studies involving minimal risk
c) For studies involving significant risk to participants
d) Only for Phase III trials

Answer 18

C

Question 19

Under 21 CFR 312.56, what must a sponsor do if there is a significant new finding during the clinical investigation that may affect the risk/benefit assessment?

A. Submit an amendment to the IND within 30 days.
B. Immediately stop the clinical trial and submit a final report.
C. Inform the FDA and all investigators, and submit a new IND application.
D. Provide an interim report at the end of the year.

Answer 19

A

Question 20

Under 21 CFR 312.37, what should a sponsor do if they wish to discontinue the clinical investigation?

A. Notify the FDA and all participating investigators, and submit a final report.
B. Immediately destroy all investigational drugs and inform the public.
C. Request an extension from the FDA and continue the study.
D. Submit a new IND application for a modified study.

Answer 20

A

Question 21

According to 21 CFR 312.40, what happens if an IND is placed on clinical hold by the FDA?
A. The clinical trial must be immediately terminated.
B. The sponsor must submit a revised IND application.
C. The sponsor must resolve the issues identified by the FDA before resuming the trial.
D. The trial can proceed with modifications as determined by the sponsor.

Answer 21

C