ACRP CCRC EXAM QUESTIONS

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ACRP CCRC EXAM QUESTIONS

Actual Qs and Ans - Expert-Verified Explanation -Guaranteed passing score -100 Questions and Answers

-Format: Multiple-choice / Flashcard

Question 1: Advocate

Answer:

Is a witness assigned as a monitor to attest to consenting process

Question 2: Required essential documents provided during study

Answer:

*updates to IB *updates to protocol / CRF, etc *approvals from IRB of updated materials *updates to any procedures / tests / shipping *records of any monitoring visits *signed ICF *completed CRFs, signed & dated *documentation of edited CRFs *source docs for completing CRFs *documentation of AEs/SAEs *subjects screening log *Subject enrollment log *subject ID code list

• investigational product accountability

*signature sheet (KSP) *record of samples

Question 3: Requirements of an IRB

Answer:

• at least 5 members
• one non-scientific member
• one non-institute member

Question 4: IEC

Answer:

Independent Ethics Committee; group who oversees protection, rights, safety & well-being of human subjects

Question 5: Reporting time frame for events

Answer:

Fatal/Life threatening unexpected = ASAP; no more than 7 days after event Non fatal/Life threatening = 15 days *ok if not all info is available --> submit what you have

Question 6: If unblinding occurs who reports & to whom?

Answer:

PI to sponsor only

Question 7: Consenting illiterate subjects

Answer:

is okay, but must have impartial witness present

Question 8: Peak

Answer:

Varies, but usually around 30 mins to several hours after dosing, depends on administration

Question 9: Who has responsibility for investigational product accountability?

Answer:

PI/Site

Question 10: Double Blind Study

Answer:

Subjects & Researchers are unaware

Question 11: Pre-Clinical Trials

Answer:

Animal/Translational Research - 4.5 years

Question 12: Legally acceptable representative

Answer:

person whom is lawfully able to consent on behalf of another

Question 13: Auditors vs Monitors vs inspectors

Answer:

*Monitors - address data, storage of drug, & report to sponsor/investigator. They can be internal *Auditors - focused on compliance which is separate from routine monitoring - they should not be part of trial; independent committee reviewing data *Inspectors - IRB or regulatory body reviewing data

Question 14: Monitors & Auditors differ in what major way?

Answer:

monitors are supplied by sponsor as part of sponsor team. Auditors are independent.

Question 15: IDMC

Answer:

Independent Data Monitoring Committee, Data & Safety Monitoring Board (DSMB), Data Monitoring Committee: Oversee safety & progress; make recommendations to continue, modify or stop

Question 16: Parallel Trial Design

Answer:

Study Group ----------------> END Control Group --------------> END

Question 17: Purpose of Trial monitoring

Answer:

*Ensure rights & safety of subjects are protected *Report on accuracy of trial data *Ensure trial is compliant (protocol, GCP, etc) Question 18: Does the PI need to notify sponsor of administrative changes to protocol, ICF, etc

Answer:

No

Question 19: an adverse drug reaction requires what level of causality?

Answer:

reasonable possibility

Question 20: Crossover Trial Design

Answer:

Study Group ----------> Control Group ------> END Control Group --------> Study Group ------> END *main issue is ample wash out time b/w crossovers

Question 21: LFTs

Answer:

Liver Function Tests Total Protein Albumin Bilirubin ALP (Alk Phos)

AST/ALT

Question 22: Single Blind Study

Answer:

Subjects Unaware Question 23: Other serious, but non-fatal / life-threatening ADRs should be reported in what time frame?

Answer:

ASAP, no more than 15 days