Research Records must be maintained a
minimum of three years after the research is completed
and the study closed with the IRB. Records may need to be kept longer if other requirements apply. Researchers must comply with the longest applicable standard as described above.
How long do you have to keep clinical research records?
In Summary: Research Records must be maintained a
minimum of three years after the research is completed
and the study closed with the IRB. Records may need to be kept longer if other requirements apply.
An investigator shall retain records required to be maintained under this part for a period of
2 years following the date a
marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication …
When should you delete research data?
The length of time you store data depends on the nature of the research project and the resultant data. Where it is workable, you should store all data (for at least the term of the project). Most researchers will store data for
at least five years after final publication
.
What kind of records is an IRB required to keep?
(c) Records the IRB administrative office must retain include, but are not limited to: (1)
Copies of all human subjects research studies reviewed
. (2) Scientific evaluations, if any, that accompany the Initial Submissions (3) Approved study consent documents. (4) Modification Submissions, and all related documentation.
How long does the sponsor have to keep clinical trial records?
(c) A sponsor shall retain the records and reports required by this part for
2 years after a marketing application is approved
for the drug; or, if an application is not approved for the drug, until 2 years after shipment and delivery of the drug for investigational use is discontinued and FDA has been so notified.
How can I protect my research data?
- Remain Current with Cybersecurity Practices. …
- Install Anti-virus Software. …
- Install a Firewall.
- Update and Patch Operating System. …
- Data Classification. …
- System Authentication and Security. …
- Data Backup Options. …
- Data Encryption.
What is the best way to store research data?
If the research plan includes long term retention of PII (in paper or electronic form), then all data files should be stored securely in a safe or locked file cabinets in a secure building. Undergraduate students should typically store their research data in
the office of their faculty advisor
.
What happens to data after research?
In general, regulation requires that
all raw data be kept for a minimum of 3-years after study completion
. If the research plan includes long term retention of PII (in paper or electronic form), then all data files should be stored securely in a safe or locked file cabinets in a secure building.
How long must consent forms be kept?
Documentation of the informed consent of the subjects – either the signed informed consent form or the short form and the written research summary – are records related to conducted research that are typically held by investigators and must be retained for
at least three years after completion of the research
, unless …
How long should IRB retain records?
Department of Health and Human Services Requirements for IRBs: 45 CFR 46.115(b) and 21 CFR 56.115(b) require that all IRB records be retained for
at least 3 years
, and records relating to research which is conducted be retained for at least 3 years after completion of the research.
What is a sponsor required to do when there is a transfer of ownership of trial data?
5.15. 1 The sponsor should ensure that it is specified in the protocol or other written agreement that the investigator(s)/
institution(s) provide direct access to source data/documents for trial-related monitoring, audits, IRB/IEC review, and regulatory inspection
.
What is included in a trial master file?
Ideally, the documents included in the TMF are:
Trial documents (protocol, investigator’s brochure, participant information documents, SOPs, instructions, manuals, guidelines, etc.)
Documents related to the Investigational Product (certificates of analysis, shipment records, storage records, etc.)
How long should essential documents be retained at the trial site?
11. How Long Must Essential Documents be Retained? The IECs/IRBs are only required to retain documents for a period of
at least 3 years after completion of the trial
.
What is one way to keep research data collected private when storing it electronically?
Research data/specimens are stored securely in
locked cabinets or rooms
. Electronic data are stored in password-protected computers or files. … Consent and HIPAA authorization forms are stored securely in locked cabinets or rooms, separately from the research data.
