SOCRA CCRP reporting timelines, etc. 2023 Flashcards
What is the dollar threshold for reporting disclosures for equity interests? And what form would be submitted to disclose this information?
Any equity interest in any publicly held sponsor more than $50,000 in value. Form 3555.
What dollar amount is the threshold for reporting significant payments of other sorts from sponsor to investigator?
More than $25,000.
How long do sponsors have to keep financial disclosure records?
2 years after application approval and until 1 year post study completion.
What organization developed the Declaration of Helsinki?
The World Medical Association/WMA.
What basic ethical principles helped lead the development of OHRPs and IRBs?
The Belmont Report for conduct of biomedical and behavioral sciences research involving human subjects.
What are the 4 components that are required for an e-records system to be part 11 compliant?
System Validation, Audit Trails, unique e-signatures and copies available for download and monitoring.
If an IND or IDE is used in an emergency situation (including drug or in vitro device) to save a human life, how many days does Investigator have to report use to IRB?
5 working days.
When using the short form ICF, who signs what components?
Subject: short form only
Witness: short form and summary/original ICF both
Physician/obtainer: summary/original ICF only
Emergency use of a drug/medical device must be reported to the IRB within how many days?
5 working days.
What does IND stand for?
Investigational New Drug.
What does IDE stand for?
Investigational Device Exemption.
How often do IRBs need to renew registration?
3 years.
What is the minimum number of IRB members required?
5 members.
How long are IRBs expected to keep records for?
3 years after study completion.
What is another name for Expanded Access Use?
Compassionate use - is a way for patients to receive drug who is not eligible, but in a life-threatening situation and no other alternatives exist.
From time of FDA approval, how long are sponsors allowed to charge for Expanded Access Use to an IND?
1 year. Sponsor may request reauthorization for additional time after.
How many days does the sponsor have to report potential serious AEs through submission of IND safety report to the FDA and investigator/site?
15 calendar days.
Serious, unexpected ADRs/AEs that are not fatal or life threatening must be filed ASAP but no later than how many calendar days?
15 calendar days.
How many days from the day a sponsor discovers a serious suspected AE do they have to submit FDA Form 3500A?
15 calendar days
How many days does sponsor have to notify the FDA of unexpected fatal or life-threatening suspected adverse reactions for IDEs?
7 calendar days after first find out
If sponsor later determines an AE is reportable, how many days after new determination does sponsor have to report this to the FDA?
15 calendar days
A sponsor must provide an annual report within ___days of anniversary date the IND went into effect.
60 days
When is an IND Application approved?
30 days after submission to FDA or unless they approve earlier
How soon can a sponsor ship an investigational new drug to a site or investigator?
When IND application is approved, i.e. 30 days after submission to FDA or on earlier FDA authorization
FDA has how many days to respond to a sponsor request to lift a clinical hold?
30 calendar days after receipt
A study in a clinical hold is considered inactive after _____year(s).
1 year or more
After how many years of being inactive will an IND be terminated?
5+ years
After how many years of being in a clinical hold will a study be terminated?
5+ years (study in clinical hold after 1 year or more is considered inactive)
How many days does a sponsor have to respond to a FDA IND termination letter?
30 days
How many days does sponsor have to request a hearing in response to FDA’s letter of nonacceptance/IND termination?
10 days
When could a study be put in inactive status?
If a clinical study has not enrolled subjects in 2+ years or if an IND has been on a clinical hold for 1+ years.
How many days does a Sponsor have to respond to the FDA if it is placed as inactive?
30 days
If an IND remains inactive for _ years, it may be terminated.
5 or more years
How long do investigators have to keep study files?
2 years after market approval or 2 years after study completion
For how long does the Sponsor have to update and maintain financial disclosure information from investigators?
For at least 1 year after study completion
For how long do investigator financial disclosures have to be maintained and updated?
During investigation and for 1 year after study completion
How long does a sponsor have to report to the FDA, IRB and investigators if sponsors determine a study is discontinued due to unreasonable risk to subjects?
5 working days
How long do sponsors have to keep complete and accurate study records?
2 years
How long does a sponsor have to retain foreign clinical trials that are used to support an IND application?
2 years after marketing approval or 2 years after submission of IND application
When is an Expanded Access Use IND approved?
30 days after submission to FDA or on earlier notification
When is an Expanded Access Use Treatment Protocol approved?
30 days after submission to FDA or on earlier notification
What is a significant risk device?
1. is intended as an implant
#2. is to be for use in supporting or sustaining human life
#3. is of substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise preventing impairment of human health, and
#4. Otherwise presents potential risk for serious risk to health, safety or welfare of subjects.
Examples include: cardiac pacemakers, hydrocephalus shunts
For how long does the sponsor have to maintain records for studies done outside the US but are used to support an IDE application?
For 2 years after termination/completion of study or for 2 years after agency decision on a premarket approval application
When is an IDE study allowed to begin?
30 days after FDA received the IDE application or earlier if FDA approves it earlier.
When making IDE changes that do not impact validity, science or safety of subject, the sponsor does not need to get prior FDA approval but does need to submit a Notice of IDE change; when does a Notice of IDE Change submission need to be made by?
Sponsor must submit to FDA by 5 working days after making change
When can a physician start treatment use of an investigational device?
30 days after IDE submission or upon earlier FDA approval
For how long do sponsors of an IDE have to update investigator financial disclosure status?
For 1 year after study completion
When must a sponsor terminate a study if it is determined that an unanticipated adverse device effect causes unreasonable risk to subjects?
Within 5 working days of determination, but no later than 15 working days after first notification of the unanticipated ADE.
An investigator of an IDE must update sponsor of financial disclosure status and changes for how long?
1 year after study completion
How long do investigators and sponsors have to maintain IDE study records for?
Either 2 years after study completion/termination or when 2 years from the date records are no longer needed to support a premarket approval application, etc., whichever is longest
If Investigator withdraws responsibility of records custody and maintenance, how long does Investigator have to submit a Notice of a transfer?
10 working days after transfer occurs
How many days does an investigator have to submit any unanticipated adverse device effects to Sponsor and IRB?
No later than 10 working days
How many days does an Investigator have to report IRB withdrawal to the Sponsor?
5 working days
What is the minimum number of Progress Reports an investigator must submit to Sponsor annually?
At least 1 per year
Protocol deviations that occurred to protect patients (emergency use) must be submitted by Investigator to Sponsor and IRB within what time frame?
5 working days after deviation occurs
If ICF is NOT collected prior to use, how many days does an investigator have to report this to the Sponsor?
5 working days after use occurs
When is the Final Report Due from Investigator to Sponsor and IRB?
3 months after study completion or termination
How many days does a Sponsor have to report investigations of unanticipated AEs to FDA?
Within 10 working days of when first learns of it from investigator
How many days does a Sponsor have to report withdrawal of IRB approval of an investigation/part of an investigation to the FDA?
5 working days after receipt
How many days does a Sponsor have to notify IRB and investigators of any FDA approval withdrawals?
5 working days of receipt of notice
How often does a Sponsor have to submit current lists of investigators to the FDA?
Every 6 months
What is the minimum a Sponsor must submit Progress Reports to the FDA of a Significant Risk device study?
Semi-annually
What is the reporting timeline for device recalls/disposals by Sponsor to FDA and IRB?
30 working days
For Significant Risk Devices, when must the Sponsor submit a Final Report to FDA?
Notification within 30 days of study completion to FDA; Final Report must be submitted to the FDA and IRB within 6 months after study completion or termination
For Non-Significant Risk Devices, when must the Sponsor submit a Final Report to FDA and IRB?
6 months after study completion or termination
If an investigator uses a device prior to collecting Informed Consent, how many days do they have to report to the Sponsor? What about Sponsor reporting to FDA?
Within 5 working days of notice of use by investigator; within 5 working days of when sponsor first notified
If IRB determines an application is a significant risk device after initial submission of a non-significant risk device, how many days does the Sponsor have to notify the FDA of this determination?
Within 5 working days of first learning of it
Per 45 CFR part 46, how often should the FDA and other agencies re-examine the meaning of “identifiable private information?”
Within 1 year of organization implementation and at least every 4 years/regularly
How long do IRBs have to keep and maintain study records?
3 years after study completion
For studies supported by Federal agencies and funding, when must the CT’s ICF be publicly posted and available by? (i.e. clinicaltrials.gov, etc.)
After clinical trial is closed to recruitment, and no later than 60 days after last study visit by any subject
How long is an IRB effective for after initial registration acceptance?
3 years
How often does IRB have to renew it’s registration?
Every 3 years
If the IRB Chairperson or contact person changes, when do these changes need to be submitted?
Submission of change to OHRP must be made within 90 days after change occurs.
How long does an IRB have to report OHRP of an IRB disbandment?
Decision to disband must be submitted to OHRP within 30 days of permanent cessation
Unexpected serious suspected adverse reactions must be reported by Sponsor to FDA within how many days?
15 calendar days from first notice
Unexpected fatal or life-threatening suspected adverse reactions must be reported to FDA ______, but no later than ____calendar days after sponsor first hears of it.
ASAP; 7 calendar days
Any additional follow-up reporting after initial safety report submission should be submitted by Sponsor to FDA within how many calendar days?
15 calendar days
