SOCRA - Society of Clinical Research Associates Essential Study Documents Questions and Answers

Question 1

A clinical trial protocol is amended to include a new secondary objective and an additional blood draw at Visit 3.
According to ICH GCP, which of the following essential documents must be updated, approved by the IRB/IEC, and implemented by the site BEFORE the changes are enacted for any new or existing participants?

Accepted Answer

The signed protocol, the informed consent form, and any other relevant written information for subjects.

Answer

The Investigator's Brochure and FDA Form 1572.

Answer

The Delegation of Authority Log and the site's Standard Operating Procedures (SOPs).

Answer

The Financial Disclosure Forms and the clinical trial agreement with the sponsor.

Question 2

On an FDA Form 1572, the Principal Investigator (PI) signs to attest they will personally conduct or supervise the investigation. In Block #6, the PI lists the names of sub-investigators who will assist in the conduct of the trial. Which of the following individuals would typically NOT need to be listed in Block #6?

Accepted Answer

A staff nurse who performs intermittent study assessments, such as vital signs, but does not make significant original contributions to the data.

Answer

A hospital pharmacist who is responsible for preparing and dispensing the investigational product according to a randomization schedule.

Answer

A fellow in the PI's department who is delegated the responsibility of obtaining informed consent and evaluating adverse events.

Answer

A co-investigator at a satellite clinic who will enroll subjects and conduct all study visits at that location.

Question 3

Which of the following essential documents is primarily intended to provide the investigator and other site staff with a comprehensive summary of the nonclinical and clinical data on the investigational product accumulated to date?

Accepted Answer

The Investigator's Brochure (IB)

Answer

The signed protocol agreement

Answer

The FDA Form 1572

Answer

The IRB/IEC approval letter

Question 4

According to ICH GCP E6(R2) Section 8, essential documents are grouped by their relevance before, during, and after the trial. Which set of documents must be on file at the investigator site BEFORE the clinical phase of the trial commences?

Accepted Answer

Signed protocol, IRB/IEC approval of the protocol and ICF, and the current Investigator's Brochure.

Answer

Monitoring visit reports, completed CRFs, and signed informed consent forms.

Answer

Final close-out report, audit certificates, and treatment allocation records.

Answer

Subject screening log, investigational product accountability records, and documentation of protocol deviations.

Question 5

A clinical investigator is participating in a pivotal Phase III drug trial intended to support a marketing application. According to 21 CFR Part 54, the investigator must provide the sponsor with sufficient financial information. The investigator must promptly update this information if any relevant changes occur during the investigation and for what period of time following the completion of the study?

Accepted Answer

For 1 year following study completion.

Answer

For 6 months following study completion.

Answer

For 2 years following study completion.

Answer

There is no requirement to update after study completion.

Question 6

An Investigator Site File (ISF) and a Trial Master File (TMF) both contain essential documents. What is the primary distinction between the two?

Accepted Answer

The ISF is maintained by the investigator at the site level, while the TMF is maintained by the sponsor and contains documents from all sites.

Answer

The ISF is maintained by the sponsor and the TMF is maintained by the investigator.

Answer

The ISF contains only source documents, while the TMF contains only regulatory documents.

Answer

The ISF is audited by the IRB/IEC, and the TMF is audited by the FDA.