CCRP EXAM SCRIPT UPDATED QUESTIONS AND
SOLUTIONS RATED A+
✔✔How long is the waiting period before a treatment IND study can be initiated? -
✔✔30 days
✔✔When will the FDA permit use of an investigational drug in widespread use? - ✔✔-If
the criteria for expanded access are met (benefits outweigh risk, illness is life
threatening, or if no other alternative treatments are available)
-If drug is being investigated in a controlled clinical trial under an IND designed to
support a marketing application for the expanded use or all clinical trials are completed
✔✔What are the steps for withdrawing an IND? (21 CFR Part 312.38) - ✔✔A sponsor
may withdraw an IND at any time without prejudice by:
-Notifying the FDA
-Stopping all studies and notifying the investigators
-Returning all drug to the Sponsor, or destroying all drug as directed by Sponsor
-If the study is withdrawn for safety reasons, the Sponsor must notify investigators and
the IRBs
✔✔Which form is used to certify absence of financial interest? - ✔✔FDA Form 3454
✔✔What form is used for the mandatory reporting of serious adverse events? - ✔✔FDA
Form 3500A
✔✔What is 21 CFR Part 50 Subpart D? - ✔✔Additional Safeguards for Children in
Clinical Investigations
✔✔What is the FDA Form 482? - ✔✔Notice of Inspection
✔✔What is 21 CFR Part 50.20 Subpart B? - ✔✔General requirements for informed
consent
✔✔What steps must be taken if IND is put on clinical hold? (CFR Part 312.42) - ✔✔-
Proposed study: Subjects may not be given the investigational drug
-Ongoing study: No recruiting of new subjects & subjects receiving investigational drug
must discontinue therapy unless specifically permitted by FDA in the interest of patient
safety
✔✔What are the reasons for clinical hold? - ✔✔-Exposure of unreasonable/significant
risk/injury to subjects
-Unqualified investigators (lack of scientific training/experience)
-Investigator brochure is misleading, erroneous, or incomplete
-IND does not contain sufficient information to assess risk to subjects of proposed
studies
, ✔✔Phase 1 Clinical Trials - ✔✔-Usually 20-80 subjects
-Meant to assess initial safety and efficacy
-Usually single center sites
✔✔Phase 2 Clinical Trials - ✔✔-Usually no more than several hundred subjects
-Multi-centered sites
✔✔Phase 3 Clinical Trials - ✔✔-Confirmation of short-term efficacy and establish long
term efficacy
-Establish benefit-risk relationship
-Provide adequate basis for labeling
-Several hundred to several thousand subjects
✔✔Phase 4 Clinical Trials - ✔✔-Post-marketing
-Continue assessing overall therapeutic value
-Size depends on design
✔✔When was the Food, Drug, and Cosmetic Act established and why? - ✔✔1938; to
establish the FDA's jurisdiction over cosmetic and medical devices in the US
✔✔What year did they amend the Federal Food Drug and Cosmetic act specifically for
medical devices? - ✔✔1976
✔✔21 CFR Part 812 - ✔✔Investigational Device Exemption
✔✔21 CFR Part 814 - ✔✔Premarket approval of medical devices
✔✔Medical device - ✔✔Device is NOT dependent on chemical action or being
metabolized and;
-also must be recognized in official national formulary or US pharmacopoeia
-intended for use in the diagnosis, treatment, mitigation or prevention of disease in man
or other animals
✔✔What are the clinical development stages for devices? - ✔✔1.) Pilot study
2.) Pivotal study
3.) Post-market studies
Compared to drugs and biologics, which typically have 1000s of subjects, device
studies usually have 100s of subjects
✔✔Class I (device) - ✔✔Lowest risk
--General controls are sufficient to provider reasonable assurance of the safety and
effectiveness
Ex. powered wheelchairs, infusion pumps, and surgical drapes
SOLUTIONS RATED A+
✔✔How long is the waiting period before a treatment IND study can be initiated? -
✔✔30 days
✔✔When will the FDA permit use of an investigational drug in widespread use? - ✔✔-If
the criteria for expanded access are met (benefits outweigh risk, illness is life
threatening, or if no other alternative treatments are available)
-If drug is being investigated in a controlled clinical trial under an IND designed to
support a marketing application for the expanded use or all clinical trials are completed
✔✔What are the steps for withdrawing an IND? (21 CFR Part 312.38) - ✔✔A sponsor
may withdraw an IND at any time without prejudice by:
-Notifying the FDA
-Stopping all studies and notifying the investigators
-Returning all drug to the Sponsor, or destroying all drug as directed by Sponsor
-If the study is withdrawn for safety reasons, the Sponsor must notify investigators and
the IRBs
✔✔Which form is used to certify absence of financial interest? - ✔✔FDA Form 3454
✔✔What form is used for the mandatory reporting of serious adverse events? - ✔✔FDA
Form 3500A
✔✔What is 21 CFR Part 50 Subpart D? - ✔✔Additional Safeguards for Children in
Clinical Investigations
✔✔What is the FDA Form 482? - ✔✔Notice of Inspection
✔✔What is 21 CFR Part 50.20 Subpart B? - ✔✔General requirements for informed
consent
✔✔What steps must be taken if IND is put on clinical hold? (CFR Part 312.42) - ✔✔-
Proposed study: Subjects may not be given the investigational drug
-Ongoing study: No recruiting of new subjects & subjects receiving investigational drug
must discontinue therapy unless specifically permitted by FDA in the interest of patient
safety
✔✔What are the reasons for clinical hold? - ✔✔-Exposure of unreasonable/significant
risk/injury to subjects
-Unqualified investigators (lack of scientific training/experience)
-Investigator brochure is misleading, erroneous, or incomplete
-IND does not contain sufficient information to assess risk to subjects of proposed
studies
, ✔✔Phase 1 Clinical Trials - ✔✔-Usually 20-80 subjects
-Meant to assess initial safety and efficacy
-Usually single center sites
✔✔Phase 2 Clinical Trials - ✔✔-Usually no more than several hundred subjects
-Multi-centered sites
✔✔Phase 3 Clinical Trials - ✔✔-Confirmation of short-term efficacy and establish long
term efficacy
-Establish benefit-risk relationship
-Provide adequate basis for labeling
-Several hundred to several thousand subjects
✔✔Phase 4 Clinical Trials - ✔✔-Post-marketing
-Continue assessing overall therapeutic value
-Size depends on design
✔✔When was the Food, Drug, and Cosmetic Act established and why? - ✔✔1938; to
establish the FDA's jurisdiction over cosmetic and medical devices in the US
✔✔What year did they amend the Federal Food Drug and Cosmetic act specifically for
medical devices? - ✔✔1976
✔✔21 CFR Part 812 - ✔✔Investigational Device Exemption
✔✔21 CFR Part 814 - ✔✔Premarket approval of medical devices
✔✔Medical device - ✔✔Device is NOT dependent on chemical action or being
metabolized and;
-also must be recognized in official national formulary or US pharmacopoeia
-intended for use in the diagnosis, treatment, mitigation or prevention of disease in man
or other animals
✔✔What are the clinical development stages for devices? - ✔✔1.) Pilot study
2.) Pivotal study
3.) Post-market studies
Compared to drugs and biologics, which typically have 1000s of subjects, device
studies usually have 100s of subjects
✔✔Class I (device) - ✔✔Lowest risk
--General controls are sufficient to provider reasonable assurance of the safety and
effectiveness
Ex. powered wheelchairs, infusion pumps, and surgical drapes
