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.
The FDA will allow electronic storage if the electronic copies are certified. As defined by the 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
- Use appropriate security measures to protect files from unauthorized access
Frequently Asked Questions
Please note: If documents are scanned into the Electronic Medical Record (EMR), they must also be stored in another location. The EMR 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 myIRB section 5.4 Privacy & Confidentiality 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?
- Yes, once all of the research records are scanned and certified, the paper copies can be destroyed.
Where should the electronic files be stored?
- Electronic files of the scanned and certified research study documents stored securely (e.g., on a Washington University server, WUSTL Box, REDCap, etc).
- 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.
- If anyone outside of the HRPO-approved research team is able to access the files (e.g., if they are stored in a general folder on the department/division share drive), the files must be password protected.
How often will central IT perform backups for data on Washington University servers?
- Back-ups are generally done once a day; however, back-up schedules may vary from one department to the next. You should contact your IT helpdesk to inquire about your department’s specific scheduled back-ups and allowable data storage.
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.
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 your protocol or an SOP, and your myIRB application has been updated to reflect electronic storage in myIRB section 5.4.
Can this be done for an ongoing (still enrolling) study?
- Yes, as long as the myIRB application reflects electronic storage and the funding entity agrees.
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.
- Bookmarks are recommended, similar to the use of tabs in a paper research record.
- 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.
- Scanned research records must be password protected if they are stored in a location accessible to anyone outside of the HRPO-approved research team (for example, a general folder on the department/division share drive). Please see the document titled “How to Bookmark & Password Protect Scanned Research Documents!” for step by step instructions.
- 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 if they are stored in a location accessible to anyone outside of the HRPO-approved research team (for example, a general folder on the department/division share drive). Please see the document titled “How to Bookmark & Password Protect Scanned Research 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 document that they certified the files. Please see the “Certification of Review of Consent Documents” and “Certification of Review of Study Documents” for examples.
- 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?
- No, not at this time.
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 the Sponsor’s permission for 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 email or letter should specify the person granting permission and their job title.
- 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?
- Yes, as long as Redcap is able to be accessed by the following groups for research oversight and compliance reviews:
- Government representatives, (including the Office for Human Research Protections and the Food & Drug Administration), to complete federal or state responsibilities
- Hospital or University representatives, to complete Hospital or University responsibilities
- Washington University’s Institutional Review Board (the committee that reviews and approves research studies).
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.