Office of Human Research
SOP No.: 703 USE OF ELECTRONIC DATA SYSTEMS
Author: Office of Human Research
Effective Date: October 1, 2007
Supercedes document dated: N/A
Last Reviewed on: N/A
Results of Review: N/A
This SOP pertains to: All FDA-regulated human subject research that is also subject to investigational new drug (IND) regulations, and investigational device exemption (IDE) regulations for medical devices, during all investigational phases of development, if electronic data management is utilized in any part of the studies. It also applies to information pertaining to investigational medical devices that may not be submitted in advance to the FDA (e.g., non-significant risk device investigations). This procedure does not apply to computerized medical devices, diagnostic laboratory devices or analytical laboratory devices that are used during a clinical study, nor does it apply to paper records that are transmitted electronically.
Responsibility for executing this SOP: Investigator and Designated Research Personnel
J. Bruce Smith, MD
Associate Vice President for Research
(signature on file at OHR)
Steven E. McKenzie, MD, Ph.D.
Vice President for Research
(signature on file at OHR)
This procedure describes the processes for the collection and transcription of clinical research data to case report forms (CRFs) or other related forms, and the management of the data, including procedures for quality control, data query resolution, record retention and archiving.
2. GENERAL INSTRUCTIONS
- Electronic data management activities occur as required by applicable regulations.
- All participating clinical sites have the appropriate tools for and are properly trained in collecting, evaluating, correcting, and transmitting participant data via electronic systems.
- Each participating site has information technology personnel available who participate as required in the implementation, monitoring and security of computerized systems used at the site.
- Computerized systems used in clinical study data management at all facilities are in compliance with applicable regulations, as regards design, validation, and routine use.
3. SPECIFIC PROCEDURES
3.1 Electronic Systems Set-up
- The Investigator is responsible for determining and documenting which elements of the study are subject to 21 CFR 11. The Investigator is responsible for creating an electronic data management plan that specifies data management systems and procedures needed for the studies.
- The Investigator should establish a timeline showing when Hardware and Software elements will be available to put into use at the Investigator's site (the study database) and at all participating study sites (electronic data capture systems).
The Investigator will do the following:
- Record all anticipated hardware (H/W) and software (S/W) that will be used in the conduct of a study on the Electronic Data Management Form (see SOP 703, Attachment A).
- Arrange to acquire all necessary H/W and S/W applications needed for the study.
- Be responsible for identifying system validation needs for off-the-shelf and customized S/W applications for their intended uses.
When setting up Electronic Data Capture ( EDC) capabilities at participating sites, the Investigator will do the following:
- Assess the ability of each site to conform to the Investigator's electronic data requirements during the site qualification visit.
- Provide all appropriate electronic data management tools (H/W, S/W, forms) to each clinical site.
- Work with the site key personnel (including site information technology or IT personnel) to facilitate setup, security, implementation, and maintenance of an FDA-compliant computerized system.
- Work with the site IT staff to ensure that computerized systems used in clinical studies have a logoff or comparable security function after a designated period of inactivity.
- Request the site's IT personnel to ensure that site personnel who have access to the computerized system(s) are assigned a unique and secure User ID/password combination.
- Request the site's IT personnel to establish and maintain a schedule for changing each individual's User ID/password combination at appropriate intervals and to invalidate stolen, lost or otherwise compromised User ID/password combinations and replace them with a new combination.
- Request the site's IT personnel to ensure that proper computer system function is routinely monitored.
- Instruct the site Investigator to ensure that Investigator -provided computerized systems are used only for the purposes for which they were intended and validated.
- Require the site Investigator to ensure that computerized systems are securely stored when not in use.
- Request the site's IT personnel to work with the Investigator to establish and securely maintain the identifier if the Investigator requires a cryptographic digital signature or a biometric-based electronic signature rather than a handwritten signature.
- Have the Monitor and other qualified personnel train all site key personnel on the proper use of Investigator -provided electronic systems used to capture study data (direct entry electronic patient diary, e-CRF), and on the relevant regulatory requirements, prior to and/or during the site initiation visit.
- Instruct site personnel not to divulge their own unique User ID/password combinations to anyone else for any purpose.
- Instruct site personnel not to use anyone else's unique User ID/password combination or perform any required computer functions under anyone else's User ID/password combination.
- Instruct site personnel to log off when computer data entry/management activities are completed.
- Train the site investigator to conduct appropriate reviews of electronic data and audit trails at designated time periods.
- Have the Monitor assess compliance with Investigator requirements regarding electronic data management during routine monitoring visits.
3.2 Electronic Data Collection and Transcription
The Investigator will ensure that:
- The clinical protocol identifies at which steps a computerized system will be used.
- All site personnel who are responsible for data entry will enter all required data into the appropriate fields of e-CRFs.
- The audit trail documents all changes to electronic records (who, when, why) and that the original entries are not overwritten.
- All annotations to electronic records are attributable as to who and when (date, time) the annotations are made.
- The site Investigator will check and correct (or annotate) all data before transmitting the e-CRF to the Investigator.
3.3 Electronic Data Management
- This will ensure that an original or certified copy of all electronic source documents and audit trail records are retained on file at the site.
- With respect to an FDA inspection, all key study personnel should treat electronic records, as they would paper records.
- The Investigator will ensure that the site investigator performs and documents audit trail reviews at defined intervals.
- The Site Investigator will retain audit trail records according to regulatory and Investigator requirements.