Sponsor's roles and responsibilities

Question 1

If sponsor obligations are assumed by a contract research organization (CRO), is that CRO subject to the same regulatory action as a sponsor for failure to comply with any regulations?

Answer 1

Yes. In this case, all references to “sponsor” apply to the CRO to the extent of which the sponsor has given them one or more obligations.

Question 2

Before permitting an investigator to begin, the sponsor shall obtain the following from them:

Answer 2

1) Form FDA-1572: Investigator statement and commitment
2) Investigator CV
3) Clinical protocol (More extensive for Phase 2/3)
4) Financial disclosure information

Question 3

What are the important components of Form FDA-1572?

Answer 3

IND numbers to be conducted by the investigator
Name and address of IRB responsible for review/approval of studies
Place where investigation will occur
Commitment by investigator to conduct the investigation according to relevant regulations

Question 4

Who is responsible for selecting the investigator(s)/institution(s) for the investigation?

Answer 4

Sponsor

Question 5

According to the ICH GCP, the sponsor should provide the investigator with what before entering into an agreement to conduct a trial?

Answer 5

The clinical trial protocol and an up to date investigator’s brochure. Should provide investigator with sufficient time to review these materials.

Question 6

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

Answer 6

Sponsor

Question 7

True or False: The sponsor is responsible for providing written procedures for handling and storage of the investigational product for the trial and documentation thereof including receipt, handling, storage, dispensing, retrieval, etc.

Answer 7

True.

Question 8

Does the sponsor or investigator submit the investigator’s brochure to the IRB? (And who keeps the IB up to date)

Answer 8

The Investigator. The sponsor is required to keep the IB up to date.

Question 9

The _____ is responsible for ongoing safety evaluation of the investigational product(s).

Answer 9

Sponsor

Question 10

Monitors are appointed by the _____.

Answer 10

Sponsor

Question 10

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

Answer 10

False. The sponsor should do this, not the investigator.

Question 10

What is the purpose of trial monitoring? (3)

Answer 10

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

Question 11

What should a sponsor monitor verify in an onsite visit in regards to the investigational product?

Answer 11

Storage times and conditions of investigational product (IP)
IP delivered to appropriate subjects
Subjects provided necessary instruction on use, storage, handling, etc. for IP
Receipt, use and return of IP is controlled and documented
Disposition of unused IP at trial sites is acceptable

Question 11

What is it called when a sponsor provides remote monitoring of the clinical trial site using a team of trained persons (e.g., data managers, biostatisticians)

Answer 11

Centralized monitoring

Question 12

True or False: According to ICH GCP, a monitoring report is optional after each trial-site visit or trial-related communication.

Answer 12

False. A monitoring report is required.

Question 12

What is included in a monitoring report?

Answer 12

Date, site, monitor, investigator’s name
Summary of what was reviewed and any significant findings
Actions to be taken or actions recommended to secure compliance
Monitoring report should be reviewed and documented by sponsor’s designated representative

Question 12

What should the monitor verify in relation to clinical report forms (CRFs)?

Answer 12

Data is reported accurately and consistent with source docs
Any dose/therapy modifications are documented
Adverse events, concomitant meds, and intercurrent illnesses are reported according to protocol
Missed visits, tests not conducted and exams not performed are clearly reported in CRF
Withdrawals and dropouts of enrolled subjects are reported and explained

Question 13

What is a monitoring plan?

Answer 13

Plan created by the sponsor tailored to subject protection and data integrity risks of the trial. This includes a monitoring strategy, responsibilities of the party, methods to be used, and rationale for their use.

Question 13

According to ICH GCP, how long after discontinuing clinical development of an investigational product does the sponsor maintain sponsor-specific essential documents?

Answer 13

2 years.

Question 14

What does an independent data monitoring committee do?

Answer 14

Assesses the progress of a trial including safety data and critical efficacy endpoints at intervals and recommends to the sponsor whether to continue, modify or stop a trial.

Question 15

According to ICH GCP, what information should be in the investigator agreement obtained by the sponsor?

Answer 15

1) Assurance that the investigator will comply with GCP, FDA, OHRP, etc. requirements
2) The investigator will comply with data recording / reporting policies
3) Investigator allows monitoring, auditing and inspection
4) Retention of essential documents by the investigator

Question 16

According to ICH GCP, if an sponsor discontinues clinical development of an investigational product, who does the sponsor notify?

Answer 16

All investigators/institutions and regulatory bodies (FDA).

Question 16

Generally, what is the responsibility of the sponsor in performing a clinical investigation?

Answer 16

Selecting qualified investigators and providing them with everything required to perform the investigation
Monitoring the trial and ensuring the trial is conducted correctly (protocol, GCP, FDA regs, etc.)
Maintaining the IND ensuring FDA is informed of any new risks

Question 17

What is the purpose of a sponsor’s audit?

Answer 17

To evaluate trial conduct and compliance with the protocol, SOPs, GCP and applicable regulatory requirements at the site.

Question 17

True or False: The sponsor is responsible for the ongoing safety evaluation of the investigational product(s).

Answer 17

True. Sponsor ultimately responsible for updating IB and notifying everyone with new safety information.

Question 17

What 4 items does a sponsor typically obtain from an investigator before having them participate in a trial?

Answer 17

A signed investigator statement/agreement (IND only, Form FDA 1572)
Investigator CV
Clinical protocol for the trial
Financial disclosure information from the investigator (FDA Form 3454 or 3455)

Question 17

When using electronic trial data handling and/or remote electronic trial data systems, what aspects of the system should the sponsor ensure are there?

Answer 17

1) ensure data changes are permitted and data isn’t deleted (audit trail)
2) Security system is in place
3) Maintain a list of authorized users who make data changes
4) Data backup
5) Safeguard blinding
6) Protect integrity of the data