Record Keeping

The IRB-SBS is responsible for keeping good records about our practices as described in the federal regulations (45 CFR 46.115). Our office maintains a digital file for each protocol including a copy of every protocol version submitted to our office (and all accompanying documents), correspondence between our office and the researcher, and any other documents relating to the continuing review of that protocol. The file is retained for at least three years after a study is closed. We also maintain records of our meeting minutes, IRB members, and standard operating procedures so that should our office be audited, we would be able to demonstrate that we are conducting ourselves according to the federal regulations. 

Likewise, any researcher who is conducting a study with an IRB approved protocol is required to maintain adequate records that correspond with his or her description in the protocol. iProtocol helps with this effort as we retain all protocol versions, approval certificates, and all versions of any uploaded document including consent forms, instruments, etc. To see your protocol's history, you can select the "Protocol History" link below each approved protocol. For more information, see Protocol History

Beyond what iProtocol retains, you will need to keep a record of the documents you use as well as the data you collect during your study. If your study includes a documenting consent, you will need to retain individualized records of the documentation. For example, if you are conducting interviews, the participant will sign a consent form prior to the interview. You should have a signed consent form for every corresponding interview. You are also required to keep your files for three years after you close your study (45 CFR 46.115).

Regardless of whether you study is ever audited, maintaining organized files will help you to protect participants.  Often for IRB-SBS studies, loss of confidentiality is the greatest risk to participants and poor organization and data management can be an easy way for loss of confidentiality to occur.