SOCRA UPDATED QUESTIONS AND
ANSWERS COMPLETE STUDY SHEET
REVIEW BUNDLE
●● 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: (Administrative Actions) 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 and which section
outlines this?
Answer: (21 CFR Part 312.31)
-If there are changes to the protocol that affects safety of subjects,
scientific quality of 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 the 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)
●● How many days does Physician or Sponsor have to submit written
summary of expanded access to the FDA after use?
Answer: 15 days
●● 21 CFR Part 312.34
Answer: Treatment use of an Investigational new drug.
●● During which phases is a treatment protocol usually made available?
Answer: During Phase 3 but if data is compelling, may be available
during Phase 2, OR, after all clinical trials have been completed and
Sponsor of trials is awaiting/pursuing marketing approval.
●● How long is the waiting period before a treatment IND study can be
initiated?
Answer: 30 days
●● When will the FDA permit use of an investigational drug in
widespread use?
Answer: -If the criteria for expanded access are met ( benefits outweigh
risk, illness is life threatening, or if no 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 and IND? 21 CFR Part 312.38
Answer: 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?
Answer: FDA Form 3454
●● What form is used for the mandatory reporting of serious adverse
events?
Answer: FDA Form 3500A
●● What is 21 CFR Part 50 Subpart D?
Answer: Additional Safeguards for Children in Clinical Investigations
ANSWERS COMPLETE STUDY SHEET
REVIEW BUNDLE
●● 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: (Administrative Actions) 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 and which section
outlines this?
Answer: (21 CFR Part 312.31)
-If there are changes to the protocol that affects safety of subjects,
scientific quality of 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 the 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)
●● How many days does Physician or Sponsor have to submit written
summary of expanded access to the FDA after use?
Answer: 15 days
●● 21 CFR Part 312.34
Answer: Treatment use of an Investigational new drug.
●● During which phases is a treatment protocol usually made available?
Answer: During Phase 3 but if data is compelling, may be available
during Phase 2, OR, after all clinical trials have been completed and
Sponsor of trials is awaiting/pursuing marketing approval.
●● How long is the waiting period before a treatment IND study can be
initiated?
Answer: 30 days
●● When will the FDA permit use of an investigational drug in
widespread use?
Answer: -If the criteria for expanded access are met ( benefits outweigh
risk, illness is life threatening, or if no 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 and IND? 21 CFR Part 312.38
Answer: 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?
Answer: FDA Form 3454
●● What form is used for the mandatory reporting of serious adverse
events?
Answer: FDA Form 3500A
●● What is 21 CFR Part 50 Subpart D?
Answer: Additional Safeguards for Children in Clinical Investigations
