Guidance for Electronic Storage of Research Study Documents
The nature and number of research protocols at Washington University has created a large volume of research study documents (including, but not limited to informed consent documents, case report forms, source documents, and study correspondence). The University recognizes the challenges and costs in storing physical copies of these documents for long periods of time, and desires to reduce these costs and ease the burden of compliance. However, the variable document retention requirements for research studies sponsored by a large number of government, for-profit, or not-for-profit entities has created significant storage issues. This guidance presents an acceptable process for creation of electronic copies of research study documents that will alleviate storage issues.
The Office of the Vice Chancellor for Research and the Human Research Protection Office surveyed major funding sources to determine their potential acceptance of electronic storage of research documents. Our findings from this survey reveal that many funders simply defer to the decision of the local Institutional Review Board (IRB). NIH defers to local IRB decisions and FDA guidance. Industry sponsors of FDA trials must follow the FDA guidance, and permission should be sought from individual sponsors prior to creation of electronic storage files. Documentation of sponsor permission should be filed with the research study documents.
FDA will allow electronic storage if the electronic copies are certified. As defined by FDA, a certified copy is a copy of original information that has been verified, as indicated by a dated signature, as an exact copy, having all of the same attributes and information as the original.
As with all research activities, the principal investigator (PI) is responsible for maintaining adequate records. The PI should therefore ensure that this guidance is followed when implementing electronic storage of research study documents.
Electronic Storage Best Practices
- Index the documents for ease of retrieval
- Certify the electronic copies
- Review of each page in the electronic document by a research team member to confirm that all pages are present and legible;
- Complete certification statement and maintain in study files; and
- Use appropriate security measures to protect files from unauthorized access
Please note: If consent documents are scanned into ClinDesk and/or Allscripts, they must also be stored in another location. ClinDesk and/or Allscripts should not be the primary permanent storage location.
Is IRB approval required when converting paper research study documents to electronic storage? When/how should the IRB be notified of intent to convert paper to electronic files?
- Yes, IRB approval is required when converting paper research study documents to electronic storage. You should submit a modification request to update Section X. Privacy & Confidentiality in myIRB to adequately reflect electronic storage of research study documents and specify the forms of electronic data protections being used.
- Please go to your project summary page in myIRB. On the right hand side you will see a section titled “Create Form”. Click on Modification/Update Form link. For more information, please see the myIRB FAQs.
Once scanned and certified; can the paper documents be destroyed?
Where should the electronic files be stored?
- Electronic files of the scanned and certified research study documents should be password protected and stored on a WU server.
It is highly recommended that research study documents not be stored on desktops, laptops, or local PCs as these devices are not backed up by the University’s IT support system.
How often will central IT perform backups?
What are other storage options?
Encrypted External Hard Drives: If external hard drives are used, the hard drives must be encrypted and backed-up onto another encrypted hard drive.
It is highly recommended that external hard drives be backed up at least once a month.
Procedures for storing and backing up external hard drives should be outlined on your myIRB application in section X. Privacy & Confidentiality.
At what point can research study documents be scanned and stored?
- Anytime, as long as the process/procedures for electronic storage of research documents are outlined in myIRB.
Can this be done for an ongoing (still enrolling) study?
- Yes, as long as the process/procedures are outlined in myIRB.
What if I have consent documents from a closed protocol?
- Closed research protocols do not need to notify the IRB of intent to convert to electronic storage. The best practice is to follow the guidance for converting these records to electronic storage. This will provide assurance that any research document can easily be retrieved if questions should arise in the future.
How should electronic files be created?
- IF SCANNING RESEARCH RECORDS OF ALL TYPES
- Research records should be scanned as a ‘chart’; that is, all of the records for a single participant should be scanned together and identified as that participant’s records (initials; participant ID). Consents should be included with each participant’s file, unless scanning all of the consent documents for the study as a separate file.
- Remember to include pertinent e-mail correspondence in the scanned file (e.g. sponsor approval of an exception).
- General study documents (delegation logs, general sponsor correspondence) should be scanned in a separate file.
- IF SCANNING CONSENT DOCUMENTS ONLY
- Consents can be scanned individually or as a group of participants.
- If scanning consents as a group, it is recommended that you keep the number of consents per .pdf in mind while considering size and number of consents per participant. (For example, you may only wish to scan 10 consents per .pdf if the consents are more than 20 pages each; however, you may wish to scan 50 consents per .pdf if the consents are only 2 pages each.)
- The .pdf file name should be labeled with the HRPO IRB number as well as the participant’s initials (For example: 201011XXX JS, JD, EP informed consents)
- Scanned consents must be password protected and bookmarked. Please see the document titled “How to Bookmark & Password Protect Scanned Informed Consent Documents!” for step by step instructions.
- Consents should be bookmarked by participant name and date signed (For example: Smith, Jane signed 7-17-2013)
- If participants have more than one consent, each consent should be labeled to clearly document this (For example: Smith, Jane PG ICF signed 7-17-2013).
- Scanned consents should NOT be saved or bookmarked by the participant’s ID number.
Can the person creating the electronic files be the person to certify the copies?
Yes, as long as they complete the Certification of Review of Electronic Files Research Consent Documents and/or Research Study Documents form.
Important Note: The person completing the certification form is certifying that they have done ALL of the following:
Reviewed all pages of the scanned document and confirmed that they are EXACT copies of the originals.
Confirmed that each scanned page is legible and facing in the appropriate direction.
Confirmed that each scanned consent is bookmarked and named appropriately.
Confirmed that the scanned document is password protected and saved in a secure location.
Can the original consent to participate be ‘signed’ electronically, without the creation of a paper document?
How long should electronic files of research study documents be kept?
Electronic files of research documents should be kept at a minimum of 7 years following submission of the close form in myIRB and in accordance with institutional policy.
Sponsored studies may have additional requirements which would need to be met in addition to institutional policy.
How should Sponsor’s permission of electronic storage of research files be documented?
Sponsors should agree to electronic storage of research documents in writing. This can be in the form of an email or letter.
This should also be captured on the Certification of Review of Electronic Files Research Consent Documents and/or Research Study Documents form.
Documentation of sponsor acceptance should be kept on file.
Can electronic storage of research study documents be done in Redcap?
If you have additional questions, please contact Andrea Morris at 314-747-5525.
*As with all research activities, the principal investigator (PI) is responsible for maintaining adequate records. The PI should therefore ensure that this guidance is followed when implementing electronic storage of consent documents.
How to Bookmark & Password Protect Scanned Informed Consent Documents
Sample Informed Consent Documents with Password Protection (Use password "201011XXX" to open)
Certification of Review of Consent Documents*
*IMPORTANT NOTE: If a login prompt appears when you attempt to access this document, click the 'Cancel' button.