Page 345 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Rec-003 SOP Title: Secured Shared Drive
Best Practice Recommendations:
• Store items in reverse chronological order, with the newest items within a section placed at the front of the section.
o Make sure to file updated versions of the documents in the appropriate tab as they become available.
• Electronic documents: The recommendation is to establish and maintain an electronic regulatory binder while complying regulations and sponsor requirements. Hard copies of the original “wet ink” signatures should be retained in a manner consistent with policy and the IRB application until the youngest enrolled participant, or latest enrolled patient whichever is more recent has reached 21 years of age. Whenever possible, electronic copies of of all other essential documents as defined by GCP, should be filed according to the following guidelines and organizational structure:
o Either a) place a note to file in the relevant location of the binder that directs an individual to the electronic location OR b) place a note to file in one location in the binder that includes a list of all documents that are stored only in electronic format, along with the specific electronic path for each item.
o AllPHIshouldbecontainedinFolder13:ScreeningandEnrollmentLog from the outline below and either; 1) locked with only administrators and study team members to have access, OR b) kept in a password protected, and encrypted file.
o Forcorrespondence,Aconcertedeffortshouldbemadetoconservethe correspondence to: Official sponsor memos, letters, and reports; information regarding subject eligibility, safety, and compliance; information that aids to support protocol deviations, S/AEs, complaints or grievances; and quality reviews, or audits; and clinical decisions. If sponsors have requirements beyond this guidance, you may want to include clarification in the binder that e-mail will be archived to a permanent storage medium on a particular schedule (specify in documentation) and the media will be stored in the binder or an easily accessible location.
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