Free Practice Questions for SOCRA CCRP Exam

TheInvestigator’s Brochure (IB)is a critical regulatory document designed to provide investigators with comprehensive knowledge about an investigational product.

ICH E6(R2) 7.1:Defines the IB as “a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects.”

ICH E6(R2) 7.2.2:Specifies the IB should contain asummary of pharmacological, toxicological, pharmacokinetic, and metabolic studies in animals, as well as results from previous human experience.

The purpose is to allow investigators to makerisk-benefit assessments, support protocol design, and ensure subject safety.

Incorrect options:

A (instructions to conduct study) describes theprotocol, not the IB.

C (financial disclosures) are required under21 CFR 54, not part of the IB.

D refers totrial master file/essential documents, not the IB.

Therefore, the IB’s defining function is to provide ascientific summary of preclinical and clinical datasupporting safe human use.

Theprotocolgoverns all trial conduct, including whether subjects should be replaced when they withdraw.

ICH E6(R2) 6.0:The protocol must contain “detailed information on trial design, methodology, statistical considerations, and the organization of the trial.”

ICH E6(R2) 6.9.2:The section on “Subject withdrawal or discontinuation” specifies “whether and under what conditions subjects may be replaced.”

Other documents serve different functions: the DSM plan (A) manages safety oversight, the IB (C) summarizes product background, and the consent form (D) explains subject rights but does not guide study conduct. Only theprotocolprovides the operational answer regarding replacement.

Thus, the correct answer isB (The protocol).

The IB must be updatedas new significant safety information emerges.

ICH E6(R2) 7.3:“The sponsor should revise the IB as soon as new, significant information becomes available.”

ICH E2A:Requires sponsors to reportSuspected Unexpected Serious Adverse Reactions (SUSARs)in expedited reports and include them inIB updates or addenda.

A SUSAR report (B) represents new, unexpected, and serious safety information not previously documented, and therefore warrants inclusion as anIB addendumuntil the IB is formally updated.

Revised consent forms (A) are submitted to IRBs, not IBs. Site-specific SAE reports (C) remain at site/sponsor level, not in the IB. Product monograph updates (D) apply to approved products, not investigational ones.

Thus, the correct answer isB (SUSAR report).

ICH E6(R2) 5.16:Sponsors must implement ongoing safety evaluation, including expedited and periodic reporting.FDA and IRB review but do not conduct active monitoring.

TheFDA record retention requirementfor investigational drug studies is clearly outlined in21 CFR 312.57(c)and21 CFR 312.62(c).

21 CFR 312.57(c):“A sponsor shall retain the records and reports… for2 years after a marketing application is approvedfor the drug; or, if an application is not approved, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.”

21 CFR 312.62(c):Investigators also must retain study-related records for2 years following the date a marketing application is approvedor 2 years after the investigation is discontinued.

This requirement ensures FDA can audit investigational product data even after approval to confirm compliance and verify trial results. Longer retention (e.g., 15 years) may be institutional or sponsor policy but is not mandated by federal law.

Thus, the correct answer isA (2 years).

Before an investigator can commit to conducting a trial, they must review thestudy protocol.

ICH E6(R2) 4.5.1:The investigator should conduct the trial in compliance with theprotocol approved by the IRB/IEC and sponsor.

ICH E6(R2) 4.2.3:The investigator should be thoroughly familiar with the appropriate use of the investigational product as described in the investigator’s brochure and the current approved protocol.

Although resources, training, and equipment are important, the fundamental step is provision of theprotocol, which forms the legal and ethical framework for study conduct. No trial agreement can be finalized until both parties agree on theprotocol details.

Monitors verify compliance with protocol, sponsor SOPs, GCP, and regulations.

ICH E6(R2) 5.18.4:Outlines monitor responsibilities, including verifying informed consent, protocol compliance, investigational product accountability, and adherence to sponsor SOPs.

Monitors must also be familiar with subject-facing documents (A) and storage requirements for investigational product (B).

However,IRB/IEC requirements for reporting to regulatory authoritiesare outside a monitor’s scope. That responsibility lies with investigators and IRBs under21 CFR 56.108(b).

Thus, the correct answer isD.

21 CFR 312.8(b):Sponsors may charge for investigational drugs only if they demonstrate that the drug providespotential clinical benefitand asignificant advantageover existing therapy.

FDA must approve charging requests.

Providing acopy of the signed consent formto subjects is a mandatory requirement.

21 CFR 50.27(a):“A copy shall be given to the person signing the form.”

ICH E6(R2) 4.8.11:Reinforces that “a copy of the signed and dated written informed consent form should be given to the subject.”

Failure to provide this copy constitutes adirect violation of informed consent regulations.

Other issues:

A & C concern proper short form process but do not invalidate informed consent if a copy was provided.

D concerns sponsor template, but the site’s responsibility is ensuring use of IRB-approved version.

Correct answer:B.

The investigator holds ultimate responsibility for all data reported.

ICH E6(R2) 4.9.1:“The investigator is responsible for the accuracy, completeness, legibility, and timeliness of the data reported to the sponsor on the CRFs and all required reports.”

Monitors (D) verify data accuracy but are not responsible for data quality. Quality specialists (B) and IRB staff (C) have no role in data entry.

Correct answer:A (The clinical investigator).