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Maintaining :: Record keeping and requesting digital copies

Record Keeping and Requesting Digital Copies

The IRB-SBS is responsible for keeping good records about our practices as described in the federal regulations (46.115). Our office maintains a file for each protocol including 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, and keeps the file 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. For example, if you conducting interviews and the participants sign a consent form prior to the interview, you should have a consent form for every corresponding interview.  You are also required to keep your files for three years after you close your study (46.115). Regardless of whether you study is ever audited, maintaining organized files will help you to protect participants.  Often for 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. For more information about maintaining records and data, please see Data Storage and Record Keeping and Consent Forms.

Records to maintain:

  • One hard copy of all documents submitted to the IRB-SBS. Although we will also keep a copy of these documents as well, there is always the possibility of loss or damage.
  • One electronic copy of the current version of all documents submitted to the IRB-SBS. Consider a naming and filing system for your documents so that you can keep track of versions as it is likely you will revise the protocol form more than once before it is closed.
  • One hard copy of the stamped consent form sent to you by the IRB-SBS after you study was approved.  This is your master copy for making additional copies to distribute to participants.

Requesting Digital Copies

If you are missing a document in your files, you can request a digital copy from our office. Complete the Digital Copies Request Form and email it to Your digital copy (PDF) will be processed and sent to you via email within 3-5 days, depending on the queue in our office.

Before you request a copy, please make every effort to locate the copy in your files and to maintain you files so that documents are not lost. While we want to accommodate researchers who need access to their materials, requests to copy lost documents can slow our efficiency in processing and reviewing protocols, making it difficult for us to help other researchers progress in their reviews. Our office keeps track of copy requests and considers an inordinate number of copy requests indicative of potential problems which may result in a PAM audit.