2024 SOCRA CCRP Reporting Timelines

45 CFR Part 46 How often must an IRB conduct continuing review of research?

At least once a year

21 CFR Part 312 How long must a sponsor retain study records?

- 2 years after a marketing application is approved for the drug - 2 years after shipment and delivery of the drug for investigational use is discontinued and the FDA has been notified

21 CFR Part 312 How long must the sponsor retain records for a foreign clinical investigation conducted under an IND?

- 2 years after an agency decision on the application - 2 years after the submission of the IND

21 CFR Part 312 How long must an investigator retain study records?

- 2 years following the date a marketing application is approved - 2 years after the investigation is discontinued and the FDA is notified

21 CFR Part 312 How often must the sponsor obtain financial disclosure information from investigators?

- During the course of the investigation if changes occur - 1 year following completion of the investigation

ICH EA2 Fatal or life-threatening unexpected adverse drug reactions must be reported to the FDA within what time frame?

- No later than 7 calendar days after the sponsor's initial awareness - A complete report must be submitted within an additional 8 calendar days

21 CFR Part 312 Under what 2 timeframes can the FDA place an IND on inactive status?

- No subjects enrolled for 2 or more years - Investigators are on clinical hold for 1 or more years

21 CFR Part 312 When can a sponsor resume activities for an investigation in an IND that is on clinical hold?

- Protocol amendment must be submitted to the FDA - 30 days after the FDAS receives the protocol amendment

45 CFR Part 46 How long must the IRB records for a study be retained?

At least 3 years after completion of the research

21 CFR Part 312 How long can charging for expanded access to an investigational drug for treatment use continue?

1 year from the time of FDA authorization

21 CFR Part 312 Records of shipments for drugs for investigational use in lab research animals must be retained for how long?

2 years after the shipment

45 CFR Part 46 How long is an IRB's registration effective?

3 years

21 CFR Part 50 Documents related to exception from informed consent requirements for emergency research must be maintained by the IRB for how long?

3 years after completion of the investigation

21 CFR Part 56 Records of an IRB must be maintained for how long?

3 years after the completion of the investigation

21 CFR Part 312 Information amendments to the IND should NOT be submitted more than every ____ days?

30

21 CFR Part 312 Protocol amendments to add new investigators or to provide additional information about investigators can be submitted at ____-day intervals?

30

21 CFR Part 312 If the FDA decides to place an IND on inactive status, how long does the sponsor have to respond to the FDA's decision?

30 days

21 CFR Part 312 If the FDA proposes to terminate an IND, how long does the sponsor have to respond?

30 days

21 CFR Part 312 When does an IND go into effect?

30 days after the FDA receives the IND

21 CFR Part 312 When does an expanded access IND go into effect/

30 days after the FDA receives the IND

21 CFR Part 312 When may the sponsor ship IMP to a site?

30 days after the FDA receives the IND

21 CFR Part 312 When will the FDA provide a written determination regarding the IND for an investigation involving an exception from informed consent?

30 days after the FDA receives the IND

21 CFR Part 312 When can expanded access use begin?

30 days after the FDA receives the protocol

21 CFR Part 312 The FDA can terminate an IND after the IND has remained on inactive status for how long?

5 or more years

21 CFR Part 56 How often must the IRB conduct continuing review of research?

At least annually

21 CFR Part 312 When must the sponsor report unexpected fatal or life-threatening suspected adverse reactions reports to the FDA?

ASAP but no later than 7 calendar days after the sponsor's initial receipt of the information

21 CFR Part 312 The FDA can place an IND on clinical hold into inactive status under what time frame?

All investigators under the IND are on clinic hold for 1 or more years

21 CFR Part 312 When must the sponsor submit background information on the sponsor's plan for a Phase III trial?

At least 1 month in advance of an end-of-Phase II meeting

45 CFR Part 46 How long must IRB records be maintained?

At least 3 years

21 CFR Part 56 How often must IRBs renew their registration?

Every 3 years

45 CFR Part 46 When must an IBR renew its registration?

Every 3 years

45 CFR Part 46 How often must the HHS review the list of categories of research that can be reviewed by the IRB through an expedited review process?

Every 8 years

21 CFR Part 312 How long can the sponsor charge for the drug in a clinical trial?

For the length of the clinical trial

21 CFR Part 312 How soon must the investigator report an SAE to the sponsor?

Immediately

21 CFR Part 312 When will the FDA provide the sponsor with a written explanation for a clinical hold?

No more than 30 days after the imposition of the clinical hold

21 CFR Part 312 IF the FDA does NOT accept the sponsors request to keep an IND active, how long does the sponsor have to request a regulatory hearing?

Must be made within 10 days of the sponsor's receipt of the FDA's notice of nonacceptance

21 CFR Part 312 When must the sponsor submit follow-up data to the FDA in regards to a safety report?

No later than 15 calendar days after receiving the request

21 CFR Part 312 If the sponsor determines that an AE not initially determined to be reportable is now reportable, the sponsor must report such an AE in what timeframe?

No later than 15 calendar days after the determination is made

21 CFR Part 312 When must the sponsor notify the FDA and investigators of any potential serious risks (e.g., SUSARs)

No later than 15 calendar days after the sponsor determines that the information qualifies for reporting

21 CFR Part 312 If a sponsor determines that the IMP presents an unreasonable risk to subjects and decides to terminate the investigation, within what timeframe must the sponsor discontinue the investigation and notify the FDA, investigators, and IRBs?

No later than 5 working days after making the determination

21 CFR Part 312 Within what timeframe must the physician or sponsor explain to the FDA how expanded access use will meet 21 CFR Part 312 requirements and submit an expanded access submission?

Within 15 working days of the FDA's authorization of use

21 CFR Part 312 If the sponsor request that the FDA's clinical hold be removed, when must the FDA respond to the sponsor's request?

Within 30 calendar days of receipt of the sponsor's request

45 CFR Part 46 If an IRB decides to disband, when must this be reported to the OHRP?

Within 30 days after permanent cessation

21 CFR Part 56 If an IRB decides to disband, when must this change be reported?

Within 30 days of the change

21 CFR Part 56 If an IRB decides to review new types of FDA-regulated products or to discontinue reviewing investigations regulated by the FDA, when must this change be reported?

Within 30 days of the change

21 CFR Part 312 When must the sponsor notify the FDA of a new investigator being added to the IND?

Within 30 days of the investigator being added

21 CFR Part 812 How soon must the sponsor notify the FDA of the completion or termination of an investigation with a significant risk device?

Within 30 working days of the completion or termination

21 CFR Part 812 IF an IRB determines that a device is a significant risk device that the sponsor had previously proposed the IRB consider NOT a significant risk device, how soon must the sponsor submit a report to the FDA of the IRB's determination?

Within 5 working days after the sponsor's initial awareness

21 CFR Part 50 If immediate use of a test article is warranted (by the PI), within what timeframe must the determination of the investigator be reviewed by an outside physician?

Within 5 working days after the use of the test article

21 CFR Part 50 If immediate use of a test article occurs, when must the investigator notify the IRB?

Within 5 working days after use of the test article

21 CFR Part 812 How soon must the sponsor inform the FDA of an investigator using a device in a subject without obtaining prior consent?

Within 5 working days of receipt of notice

21 CFR Part 812 How soon must the sponsor submit a final report to the FDA, IRBs, and investigators of the completion/termination of an investigation involving a significant risk device?

Within 6 months after completion/termination

21 CFR Part 312 When must the sponsor submit a progress report of the investigation?

Within 60 days of the anniversary date the IND went into effect

45 CFR Part 46 If the contact information of the contact person for the IRB changes, when must the IRB update its registration information?

Within 90 days after the change

21 CFR Part 56 If an IRB's contact or chairperson information changes, when must this information be submitted to the FDA?

Within 90 days of the change