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.
How long should researchers keep data?
Federal regulations require research records to be retained for at least 3 years after the completion of the research (45 CFR 46) and UVA regulations require that data are kept for at least 5 years. Additional standards from your discipline may also be applicable to your data storage plan.
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 .
How long does data need to be kept for IRB?
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.
How will the research data be archived or destroyed when the data is no longer required?
When data are no longer required, destroy non-electronic media using secure means to render it safe for disposal or recycling . Commonly used methods include cross-cut shredders, pulverizers, and incinerators.
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 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.
When can sponsor destroy any study records?
Any data collected during the time the subject was actively enrolled , before withdrawal from the trial, should not be destroyed. The sponsor must retain records/data that were collected during the trial, prior to subject’s withdrawal.
How do you securely destroy research data?
When data are no longer required, destroy non-electronic media using secure means to render it safe for disposal or recycling. Commonly used methods include cross-cut shredders, pulverizers, and incinerators .
How long must consent forms be kept?
Signed informed consent forms are to be retained for at least 3 years following the close of the study .
How can I safely destroy data?
- Delete/Reformat.
- Wipe.
- Overwriting data.
- Erasure.
- Degaussing.
- Physical destruction (drill/band/crush/hammer)
- Electronic shredding.
- Solid state shredding.
How do you destroy data?
- Delete/Reformat.
- Wipe.
- Overwriting data.
- Erasure.
- Degaussing.
- Physical destruction (drill/band/crush/hammer)
- Electronic shredding.
- Solid state shredding.
How can we destroy online data after research?
Methods of destruction/disposal should destroy data permanently and irreversible. Methods may include overwriting data with a series of characters or reformatting the disk (destroying everything on it). Pulverizing the hard disk is the best method of destroying hard disk data.
How do you protect data collected?
- Only collect the most vital data.
- Limit access to that data.
- Use password management tools.
- Avoid data silos.
- Set minimum security standards.
What is the most secure way to store data?
The most secure way to store data is the way that works best for them and keeps their copies apart from the originals. One option that is used by around a fifth of SMEs is to copy data to an external hard drive that is then removed from the premises each evening.
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.
