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.
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 must clinical research records should be kept?
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 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.
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.
At which study visits can the site expect?
At which study visits can the site expect the sponsor to review subjects’ signed informed consent forms?
Periodic and termination site visits
. The subject informed consent forms are reviewed at the periodic site visits and the termination site visit.
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 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.
How should data be stored?
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 essential documents be retained?
Essential documents should be retained until
at least 2-years after the last approval of a marketing application in an
ICH region and until there are no pending or contemplated marketing applications in an ICH region.
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.)
WHEN CAN protocol deviations occur?
Protocol deviation. A protocol deviation occurs when, without significant consequences,
the activities on a study diverge from the Institutional Review Board-approved protocol
, e.g., missing a visit window because the subject is traveling. Not as serious as a protocol violation.
What is a site selection visit?
Site Qualification Visit (SQV):
A meeting with a representative from a sponsor representative to ensure the institution is fully capable and equipped to run
a specific clinical trial. This visit may also be referred to as Site Selection Visit (SSV) or Pre-Study Qualification Visit (PSQV).
Who is responsible for making the initial?
Who is responsible for making the initial risk determination for a device being used in a study?
The sponsor-investigator
. The sponsor-investigator is responsible for making the initial risk determination and presenting it to the IRB.
What is a protocol violation?
Protocol violations are
any unapproved changes, deviations or departures from the study design or procedures of a research project that are under the investigator’s control
and that have not been reviewed and approved by the IRB.
How do companies destroy data?
Organizations can physically destroy data in a number of ways, such as
disk shredding
, melting or any other method that renders physical storage media unusable and unreadable.
