Timelines Flashcards
How many days does a sponsor have to report an emergency use of an IP to the FDA
5 WD
How long must an IRB retain records per 21 CFR 56
3 years after completion of research
How many days does the IRB have to report a change in registration info due to a change in chairperson or contact?
90
How many days does an IRB have to inform the FDA that it is reviewing different types of FDA products?
30
How oftem must an IRB renew its registration
3 years
Sponsors must report SAEs to the FDA within how many days of discovering the event?
15 calendar days
Investigators must report SAEs toa sponsor within how many days of discovering the event?
immediately
Sponsors must report what kind of serious events to the FDA within 15 calendar days?
- serious and unexpected AR
- Findings from other studies that suggest a significant risk in humans
- Findings from animal or in-vitro testing that suggest risks to humans
- increased rate of occurrence of serious suspected ARs
Sponsors must submit unanticipated adverse device effects to the FDA within how many days?
10 WD
Investigator retains study records for ____ years after date a marking application is approved for indication for which it was investigated or for _____ years after an investigator was discontinued and FDA notified
2 years 2 years
How many day sdoes a sponsor have to submit a report to the FDA/ investigators/IRBs aout withdrawal of IRB approval
5wd
How many days does a sponsor have to submit a report to investigators/IRB about withdrawal of FDA approval
5wd
How many days does a sponsor have to submit a report to FDA/ Investigators/ IRB about returns, repairs or disposal of units of a device?
notive to be provided within 30 days
How many days does a sponsor have to submit a report to FDA about SR DEVICE IF SPONSOR SUGGESTED NSR
5WD
wwhen must a sponsor submit a brief report of investigation progress to FDA for drug trials
within 60 days of anniversary date that IND went into effect
Within ho wmany days should a sponsor notify the FDA of the completion/termination of a SR device trial
30 working days
(b) The records required by Basic HHS Policy for Protection of Human Research Subjects shall be retained for at least ____ years, and records relating to research that is conducted
shall be retained for at least ____ years after completion of the research.
3, 3
(3) The informed consent form must be posted on the Federal Web site after the clinical trial is closed to recruitment, and no
later than ____ days after the last study visit by any subject, as required by the protocol.
60
when is a decision on the NDA supposed to be made?
within 12 months of submission
When an emergency use of an investigator drug is given, how soon must it be reported to IRB?
within 5 days of use
When should progress reports be submiitted to IRB for IDE?
yearly
For SR IDE, where are progress reports sent and how often
FDA, YEARLY
- An unexpected fatal or life threatening
experience associated with the use of the drug
must be reported to FDA in writing no later than
___ calendar days after the receipt of information* Followed by a written report no more than ____
calendar days after the initial receipt of
information
7, 15
IND safety reports. The sponsor must notify FDA and all participating investigators (i.e., all investigators to whom the
sponsor is providing drug under its INDs or under any investigator’s IND) in an IND safety report of potential serious risks, from
clinical trials or any other source, as soon as possible, but in no case later than _________ calendar days after the sponsor determines
that the information qualifies for reporting
15
The sponsor must submit each IND safety report in a narrative format or on FDA Form
3500A or in an electronic format that FDA can process, review, and archive. FDA will periodically issue guidance on how to
provide the electronic submission (e.g., method of transmission, media, file formats, preparation and organization of files). The
sponsor may submit foreign suspected adverse reactions on a Council for International Organizations of Medical Sciences
(CIOMS) I Form instead of a FDA Form 3500A. Reports of overall findings or pooled analyses from published and unpublished in
vitro, animal, epidemiological, or clinical studies must be submitted in a narrative format. Each notification to FDA must bear
prominent identification of its contents, i.e., “IND Safety Report,” and must be transmitted to the review division in the Center for
Drug Evaluation and Research or in the Center for Biologics Evaluation and Research that has responsibility for review of the IND.
Upon request from FDA, the sponsor must submit to FDA any additional data or information that the agency deems necessary, as
soon as possible, but in no case later than _________ calendar days after receiving the request.
15
If the results of a sponsor’s investigation show that an adverse event not initially determined to be reportable under
paragraph (c) of this section is so reportable, the sponsor must report such suspected adverse reaction in an IND safety report as
soon as possible, but in no case later than ______ calendar days after the determination is made
15
If the sponsor responds but FDA does not accept the explanation or correction submitted, FDA shall inform the sponsor in
writing of the reason for the nonacceptance and provide the sponsor with an opportunity for a regulatory hearing before FDA
under part 16 on the question of whether the IND should be terminated. The sponsor’s request for a regulatory hearing must be
made within __________ days of the sponsor’s receipt of FDA’s notification of nonacceptance.
10
Final report. In the case of a significant risk device, the sponsor shall notify FDA within ______ working days of the completion
or termination of the investigation and shall submit a final report to FDA and all reviewing the IRB’s and participating investigators
within ________ after completion or termination. In the case of a device that is not a significant risk device, the sponsor shall
submit a final report to all reviewing IRB’s within ________ after termination or completion.
30, 6 months x2
How often must a sponsor submit current list of investigators
ever 6 months
A sponsor who determines that an unanticipated adverse device effect presents an unreasonable risk to subjects shall
terminate all investigations or parts of investigations presenting that risk as soon as possible. Termination shall occur not later than
____ working days after the sponsor makes this determination and not later than _______ working days after the sponsor first received
notice of the effect.
5, 15
Unanticipated adverse device effects. A sponsor who conducts an evaluation of an unanticipated adverse device effect
under §812.46(b) shall report the results of such evaluation to FDA and to all reviewing IRB’s and participating investigators within
__ working days after the sponsor first receives notice of the effect. Thereafter the sponsor shall submit such additional reports
concerning the effect as FDA requests.
10
When would. Protocol amendment of a new investigator need to be submitted
Sponsor must notify FDA of new investigators with 30 days of being added.
Sponsor must submit protocol amendment when a new investigator is added to carry out a previously submitted protocol
No subjects enrolled for a period of ___ or more years or if investigator remains on hold for __ year or more
sponsor is not required to submit annual reports to an inactive IND
To resume clinical investigations under an inactive IND, sponsor must submit a protocol amendment containing proposed general investigational plan IND that means on inactive status for ___ years will be terminated
2
1
5
CFR requires who to sign for ICF
subject
ICH E6 R2 requires who to sign the ICF
subject and individual performing consent to sign
