CCRP Exam Dumps - Certified Clinical Research Professional (CCRP)

India has aligned national regulations with ICH-GCP.

DCGI/ICMR Guidelines (India):Explicitly adopt ICH E6(R2) as part of its Good Clinical Practice standards.China and Brazil are harmonizing, but full official adoption is noted in India.

Source documentsare the original records where trial data are first recorded, from which Case Report Form (CRF) entries are verified.

ICH E6(R2) 1.52:Defines source documents as “original documents, data, and records (e.g., hospital records, clinical and office charts, laboratory notes, pharmacy dispensing records, recorded data from automated instruments, etc.).”

ICH E6(R2) 8.3.13:Requires maintenance of “source documents” to verify data integrity and allow monitoring/audits.

Pharmacy dispensing records (D) fit this definition, as they show initial data on investigational product dispensing and accountability. In contrast, subject instruction sheets (A) are communication tools, SOPs (B) are procedural guides, and the protocol (C) is a governing document, none of which qualify as original data records.

Therefore, the correct answer isD (Pharmacy dispensing records).

21 CFR 312.56(d):If an IND is withdrawn for safety, the sponsor must notifyFDA and all participating investigators, who in turn notify IRBs.

Ensures subjects are protected and sites stop enrollment.

IRBs must be diverse and independent to protect human subjects.

21 CFR 56.107(d):“Each IRB shall include at least one member whose primary concerns are in nonscientific areas… andat least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person affiliated with the institution.”

There is no minimum requirement of seven members (A). Nonscientists must be represented but not a majority (B). Clergy are not mandated (C). The critical safeguard is inclusion of at leastone unaffiliated member (D)to ensure independence.

Thus, the correct answer isD (At least one unaffiliated individual).

Form FDA 1572 is the “Statement of Investigator” for IND studies.

21 CFR 312.53(c)(1)(vi)(b):Requires investigators to “read and understand the Investigator’s Brochure.”

By signing, the investigator also agrees to comply with regulations, maintain records, and supervise study conduct.

Other options (B–D) are not part of 1572 requirements.

Correct answer:A.

ICH E6(R2) 5.13.3:The sponsor is responsible for the supply, storage, and final disposition of investigational product.

21 CFR 312.59:Sponsors must assure return or proper disposition of unused supplies.

Sites must followsponsor’s written proceduresfor reconciliation, return, or destruction, not IRB or pharmacy processes.

Audits are part of sponsor quality assurance to ensure trial compliance.

ICH E6(R2) 5.19.3:“The sponsor’s auditing procedures should include the provision of anaudit certificatewhere required.”

ICH E6(R2) 8.2.20:Audit certificates are essential documents generated and retained by the sponsor.

IRBs (A), regulators (B), and DSMBs (C) are not responsible for audit documentation. Therefore, only thesponsorissues and maintains audit certificates, providing them to sites when appropriate.

Correct answer:D.