CCRP STUDY SHEET 2026 COMPLETE
QUESTIONS GUARANTEED PREP GRADED
A+
⩥ What information must the general IND include? (21 CFR Part
312.23) Answer: FDA Form 1571:
-FDA Form 1571 cover sheet
-Table of contents
-Investigative plan
-Investigator's brochure
-Protocol
-Chemistry/Manufacturing information
-Pharmacology/toxicology
-Previous human research/literature information
-Additional information (drug dependence and abuse potential)
⩥ How many days after FDA receives IND submission does the IND go
into effect? (21 CFR 312.40) Answer: An IND goes into effect 30 days
after the FDA receives the submission unless the FDA notifies the
Sponsor of a clinical hold
, ⩥ When must an IND amendment be submitted? (21 CFR Part 312.31)
Answer: -If there are changes to the protocol that affects safety of
subjects, scientific quality of the study, or scope of investigation
-If a new investigator is added to the study
-Information amendments must be submitted for
chemistry/microbiology, pharm/toxicology, or clinical
OTHER SUBMISSIONS:
--IND safety reports
--Response to clinical hold
--Response to FDA request for information
--IRB Annual report
⩥ What are t he requirements for expanded access? (21 CFR Part
312.300 - Subpart 1) Answer: -Population must have serious or life-
threatening disease or condition
-No comparable/significant alternate therapy/treatment
-Patient cannot obtain drug under another IND or protocol
-Potential benefit outweighs risks of treatment
-Expanded access won't interfere with completion of studies that could
support marketing approval
-Must apply to treatment protocols and should be for individual use (1
person)
QUESTIONS GUARANTEED PREP GRADED
A+
⩥ What information must the general IND include? (21 CFR Part
312.23) Answer: FDA Form 1571:
-FDA Form 1571 cover sheet
-Table of contents
-Investigative plan
-Investigator's brochure
-Protocol
-Chemistry/Manufacturing information
-Pharmacology/toxicology
-Previous human research/literature information
-Additional information (drug dependence and abuse potential)
⩥ How many days after FDA receives IND submission does the IND go
into effect? (21 CFR 312.40) Answer: An IND goes into effect 30 days
after the FDA receives the submission unless the FDA notifies the
Sponsor of a clinical hold
, ⩥ When must an IND amendment be submitted? (21 CFR Part 312.31)
Answer: -If there are changes to the protocol that affects safety of
subjects, scientific quality of the study, or scope of investigation
-If a new investigator is added to the study
-Information amendments must be submitted for
chemistry/microbiology, pharm/toxicology, or clinical
OTHER SUBMISSIONS:
--IND safety reports
--Response to clinical hold
--Response to FDA request for information
--IRB Annual report
⩥ What are t he requirements for expanded access? (21 CFR Part
312.300 - Subpart 1) Answer: -Population must have serious or life-
threatening disease or condition
-No comparable/significant alternate therapy/treatment
-Patient cannot obtain drug under another IND or protocol
-Potential benefit outweighs risks of treatment
-Expanded access won't interfere with completion of studies that could
support marketing approval
-Must apply to treatment protocols and should be for individual use (1
person)
