In this Section

REDCap Compliance

HIPAA Compliance Statement

REDCap is an application used to enter, validate, maintain, and retrieve data which uses a MySQL database via a secure (SSL) web interface with data checks used during data entry to ensure data quality. REDCap includes a complete suite of features to support HIPAA compliance, including a full audit trail, user-based privileges, and the ability to integrate with the EVMS LDAP server. The MySQL database and the web server are both housed on secure servers maintained by the EVMS Academic Computer Center (ACC). The servers are in a physically secure location on campus and are backed up nightly, with the backups stored in accordance with the ACC retention policy. Weekly backup tapes are stored offsite. The ACC servers provide a stable, secure, well-maintained, and high-capacity data storage environment, and both REDCap and MySQL are widely-used, powerful, reliable, well-supported systems. Access to a study's data in REDCap is restricted to the members of that study team by username and password.

 


 

21 CFR Part 11 Compliance


21 CFR Part 11-Capable Configuration

Part 11 requires both procedural controls (i.e. notification, training, SOPs, administration) and administrative controls (i.e. policy, approvals) to be put in place by the consortium partner host institution in addition to the software controls that contain the required technical elements of a compliant system.

The following table provides a detailed assessment of how a REDCap version 7.3.1 database configured using the optional features available can be “21CFR 11 Capable” can facilitate compliance with 21CFR Part 11. The term “agree” is used to acknowledge portions of the Scope where there is no technical control or action required on the part of REDCap software. This indicates the recommendation has been read and understood, and will be addressed by procedural or administrative means at the individual site. The term “consortium partner” refers to the academic or not-for-profit research institution that is the legal entity holding a REDCap license and hosting the study that uses the software for a study that must be compliant.

Subpart A— General Provisions

21 CFR 11.1 ScopeREDCap Compliance
(a) The regulations in this part set forth the criteria under which the agency considers electronic records, electronic signatures, and handwritten signatures executed to electronic records to be trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed on paper. Agree
(b) This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations. This part also applies to electronic records submitted to the agency under requirements of the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act, even if such records are not specifically identified in agency regulations. However, this part does not apply to paper records that are, or have been, transmitted by electronic means. Agree
(c) Where electronic signatures and their associated electronic records meet the requirements of this part, the agency will consider the electronic signatures to be equivalent to full handwritten signatures, initials, and other general signings as required by agency regulations, unless specifically excepted by regulation(s) effective on or after August 20, 1997. REDCap installations support electronic signatures by positively identifying the user through a unique username and password combination. This information can be controlled and managed by a variety of means that a site can choose, including LDAP and table-based authentication.
(d) Electronic records that meet the requirements of this part may be used in lieu of paper records, in accordance with Sec. 11.2, unless paper records are specifically required. The consortium partner is responsible for this requirement.
(e) Computer systems (including hardware and software), controls, and attendant documentation maintained under this part shall be readily available for, and subject to, FDA inspection. The consortium partner is responsible for this requirement.

 

21 CFR 11.2 ImplementationREDCap Compliance
(a) For records required to be maintained, but not submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that the requirements of this part are met. Agree
(b) For records submitted to the agency, persons may use electronic records in lieu of paper records or electronic signatures in lieu of traditional signatures, in whole or in part, provided that: Agree
(1) The requirements of this part are met; and Agree
(2) The document or parts of a document to be submitted have been identified in public docket No. 92S-0251 as being the type of submission the agency accepts in electronic form. This docket will identify specifically what types of documents or parts of documents are acceptable for submission in electronic form without paper records and the agency receiving unit(s) (e.g., specific center, office, division, branch) to which such submissions may be made. Documents to agency receiving unit(s) not specified in the public docket will not be considered as official if they are submitted in electronic form; paper forms of such documents will be considered as official and must accompany any electronic records. Persons are expected to consult with the intended agency receiving unit for details on how (e.g., method of transmission, media, file formats, and technical protocols) and whether to proceed with the electronic submission. The consortium partner is responsible for this requirement

 

21 CFR 11.3 - General ProvisionsREDCap Compliance
(a) The definitions and interpretations of terms contained in section 201 of the act apply to those terms when used in this part Agree
(b) The following definitions of terms also apply to this part: Agree
(1) Act means the Federal Food, Drug, and Cosmetic Act (secs. 201-903 (21 U.S.C. 321-393)) Agree
(2) Agency means the Food and Drug Administration Agree
(3) Biometrics means a method of verifying an individual’s identity based on measurement of the individual’s physical feature(s) or repeatable action(s) where those features and/or actions are both unique to that individual and measurable. The use of biometrics is not supported by REDCap.
(4) Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. REDCap can be configured as either an open or closed system; closed is recommended.
(5) Digital signature means an electronic signature based upon cryptographic methods of originator authentication, computed by using a set of rules and a set of parameters such that the identity of the signer and the integrity of the data can be verified. REDCap uses User Rights settings that uniquely identify the user from their username and password combination. The internal security settings in these tools determine the access and privileges of the signed in user
(6) Electronic record means any combination of text, graphics, data, audio, pictorial, or other information representation in digital form that is created, modified, maintained, archived, retrieved, or distributed by a computer system. Agree
(7) Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature. REDCap supports electronic signatures by positively identifying the user through a unique username and password combination. Optional Esignature module adds functionality including reason and meaning for Esignature recorded in the audit log when a change is made to data in the record. The consortium partner is responsible for authorization of the electronic signature as the equivalent of the handwritten signature.
(8) Handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate in writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark.

The use of biometrics is not supported by REDCap.

REDCap can produce PDF versions of records that can be printed for handwritten signature and date. The downloaded and printed data cannot be imported back into the database without record of the event in the audit trail.
The download is reported in the audit trail

(9) Open system means an environment in which system access is not controlled by persons who are responsible for the content of electronic records that are on the system. REDCap can be configured as either an open or closed system; closed is recommended.

 

Subpart B -  Electronic Records

The FDA distinguishes between open and closed systems. Closed systems are those where access is controlled by persons who are responsible for the content of electronic records on the system. Open systems are accessible by those who are not directly responsible for the electronic records on the system.

21 CFR 11.10 – Controls for Closed SystemsREDCap Compliance
Persons who use closed systems to create, modify, maintain, or transmit electronic records shall  employ procedures and controls designed to ensure the authenticity, integrity, and, when appropriate, the confidentiality of electronic records, and to ensure that the signer cannot readily repudiate the signed record as not genuine. Such procedures and controls shall include the following: Because REDCap is client/server application that uses an IP address and port to access the database and they require a unique username and password combination, the administrator can set up a closed system in which access is limited internally to the server
(a) Validation of systems to ensure accuracy,reliability, consistent intended performance, and the ability to discern invalid or altered records.  The consortium partner can use the REDCap audit trail to discern between valid and invalid records. REDCap maintains an audit trail that cannot be altered without evidence of change. The consortium posts Functional Requirements and templates for validation test scripts for each Long Term Support version release. The consortium partner is responsible for documentation of the executed scripts.
(b) The ability to generate accurate and complete copies of records in both human readable and electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there are any questions regarding the ability of the agency to perform such review and copying of the electronic records REDCap reports include username who made changes, the date/time stamp; the type of change and reason for change and comments can be included. The full record history can be tracked and reassembled from this log. These reports can be distributed in paper or electronic form. The history of each field is available onscreen
(c) Protection of records to enable their accurate and ready retrieval throughout the records retention period.  The security within REDCap gives complete control over which users can complete specified actions when using these tools. The consortium partner is responsible for backing up and protecting the records
(d) Limiting system access to authorized individuals. REDCap uses security settings that uniquely identify the user from their username and password combination. The internal security settings in the tools determine the access and privileges of the signed in user for each form and tool. The consortium partner is responsible for implementing secure hosting
(e) Use of secure, computer-generated, time- stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records. Record changes shall not obscure previously recorded information. Such audit trail documentation shall be retained for a period at least as long as that required for the subject electronic records and shall be available for agency review and copying The history of the actions completed within REDCap in the audit trail is used for validation purposes REDCap maintains a distinct audit trail that can be retained indefinitely.  The history of each field is available onscreen. Audit file can be downloaded for review and copying
(f) Use of operational system checks to enforce permitted sequencing of steps and events, as appropriate. REDCap controls cannot enforce sequencing of workflow. The consortium partner is responsible for enforcing proper sequencing of steps and events, The ability to complete any given action is controlled at the security setting for the user and is under the control of the administrator(s) to set what permissions are allowed to what users to make what changes at any given point in the process. The history of actions completed within REDCap contains timestamp information for when the action was completed and by what user, showing the sequence in which actions occurred.
(g) Use of authority checks to ensure that only authorized individuals can use the system, electronically sign a record, access the operation or computer system input or output device, alter a record, or perform the operation at hand  REDCap uses a set of rules based on security settings that uniquely identify the user from their username and password combination. The internal security settings in these tools determine the access and privileges of the logged in user.
(h) Use of device (e.g., terminal) checks to determine, as appropriate, the validity of the source of data input or operational instruction REDCap cannot interface with devices; administrators can restrict what actions can be done through the security settings
(i) Determination that persons who develop, maintain, or use electronic record/electronic signature systems have the education, training, and experience to perform their assigned tasks Access is controlled via security settings to those individuals deemed appropriate.
The consortium partner is responsible for this requirement
(j) The establishment of, and adherence to, written policies that hold individuals accountable and responsible for actions initiated under their electronic signatures, in order to deter record and signature falsification. The consortium partner is responsible for this requirement.
(k) Use of appropriate controls over systems documentation including: Agree
(1) Adequate controls over the distribution of, access to, and use of documentation for system operation and maintenance. There is online help and documentation. Printed copies of documents and guides can be made available. The consortium partner is responsible for this requirement.
(2) Revision and change control procedures to maintain an audit trail that documents time- sequenced development and modification of systems documentation The history of the actions completed within REDCap maintains a distinct audit trail for this purpose. History of ach field can be viewed onscreen.
21 CFR 11.30 – Controls for Open SystemsREDCap Compliance
Persons who use open systems to create, modify, maintain, or transmit electronic records shall employ procedures and controls designed to ensure the authenticity, integrity, and, as appropriate, the confidentiality of electronic records from the point of their creation to the point of their receipt. Such procedures and controls shall include those identified in Sec. 11.10, as appropriate, and additional measures such as document encryption and use of appropriate digital signature standards to ensure, as necessary under the circumstances, record authenticity, integrity, and confidentiality REDCap can be used as an open system or a closed system depending on the access to the server via an IP address and port. Through the use of the username and password combination and internal security settings the administrator has the ability to secure the system as required for compliance.
21 CFR 11.50 - Signature ManifestationsREDCap Compliance
(a) Signed electronic records shall contain information associated with the signing that clearly indicates all of the following REDCap uses the username and password combination to uniquely identify the logged in user. LDAP support allows the use of an LDAP server to manage user compliance. REDCap provides table based controls
(1) The printed name of the signer The full name of the signer is displayed on the homepage with the username
(2) The date and time when the signature was executed A date and timestamp are contained in the history.
(3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature The meaning associated with the signature is entered in text which is saved in a field in the audit trail and cannot be modified.
(b) The items identified in paragraphs (a)(1), (a)(2), and (a)(3) of this section shall be subject to the same controls as for electronic records and shall be included as part of any human readable form of the electronic record (such as electronic display or printout). REDCap audit trail includes this information in the audit trail for electronic signature events.
21 CFR 11.70 - Signatures / Record LinkingREDCap Compliance
Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means The audit trail history of events in REDCap is not modifiable and contains the details of the action taken as well as a timestamp; the user who performed the action; and the reason.

 

Subpart C - General Provisions

21 CFR 11.100 - General RequirementsREDCap Compliance
(a) Each electronic signature shall be unique to one individual and shall not be reused by, or reassigned to, anyone else. The unique username and password combination required by REDCap ensures the user is authenticated when logging in. The consortium partner is responsible for ensuring usernames cannot be reassigned
(b) Before an organization establishes, assigns, certifies, or otherwise sanctions an individual’s electronic signature, or any element of such electronic signature, the organization shall verify the identity of the individual The administrator is responsible for verifying that each user entered into the system is properly identified before entering a unique username and password combination for said user. LDAP can be used to centrally manage users. The consortium partner is responsible for this requirement.
(c) Persons using electronic signatures shall, prior to or at the time of such use, certify to the agency that the electronic signatures in their system, used on or after August 20, 1997, are intended to be the legally binding equivalent of traditional handwritten signatures The consortium partner is responsible for this requirement.
(1) The certification shall be submitted in paper form and signed with a traditional handwritten signature, to the Office of Regional Operations (HFC-100), 5600 Fishers Lane, Rockville, MD 20857 The consortium partner is responsible for this requirement.
(2) Persons using electronic signatures shall, upon agency request, provide additional certification or testimony that a specific electronic signature is the legally binding equivalent of the signer’s handwritten signature The consortium partner is responsible for this requirement.
21 CFR 11.200 - Electronic Signature Components and ControlsREDCap Compliance
(a) Electronic signatures that are not based upon biometrics shall Agree
(1) Employ at least two distinct identification components such as an identification code and password REDCap uses a username and password combination to identify the logged in User
(i) When an individual executes a series of signings during a single, continuous period of controlled system access, the first signing shall be executed using all electronic signature components; subsequent signings shall be executed using at least one electronic signature component that is only executable by, and designed to be used only by, the individual REDCap requires the user initiate a continuous period of controlled system access with a username and password combination. The password alone is sufficient for electronic signatures on events executed in a continuous session after the first signature.
(ii) When an individual executes one or more signings not performed during a single, continuous period of controlled system access, each signing shall be executed using all of the electronic signature components. REDCap requires the user execute individual electronic signings with both a username and password combination for individual electronic signatures.
(2) Be used only by their genuine owners The consortium partner is responsible for this requirement
(3) Be administered and executed to ensure that attempted use of an individual’s electronic signature by anyone other than its genuine owner requires collaboration of two or more individuals. This is a procedural issue that is the responsibility of the consortium partner. The “Administrator” user has the ability to manage and maintain all users and passwords. The “Administrator” user can change any user’s password if necessary.
(b) Electronic signatures based upon biometrics shall be designed to ensure that they cannot be used by anyone other than their genuine owners The use of biometrics is not supported by REDCap.
21 CFR 11.300 – Controls for Identification Codes/Passwords REDCap Compliance
Persons who use electronic signatures based upon use of identification codes in combination with passwords shall employ controls to ensure their security and integrity. Such controls shall include REDCap requires that a named user logs into the application
(a) Maintaining the uniqueness of each combined identification code and password, such that no two individuals have the same combination of identification code and password.

REDCap uses a username and password to uniquely identify the person logged into the system. Usernames must be unique and are not case sensitive. All records created by a user are permanently linked to the user’s unique username
(b) Ensuring that identification code and password issuances are periodically checked, recalled, or revised (e.g., to cover such events as password aging) Administrators can set strong passwords rules LDAP can also be used to centrally manage users. The consortium partner is responsible for this requirement.
(c) Following loss management procedures to electronically de-authorize lost, stolen, missing, or otherwise potentially compromised tokens, cards, and other devices that bear or generate identification code or password information, and to issue temporary or permanent replacements using suitable, rigorous controls. REDCap does not support devices.
(d) Use of transaction safeguards to prevent unauthorized use of passwords and/or identification codes, and to detect and report in an immediate and urgent manner any attempts at their unauthorized use to the system security unit, and, as appropriate, to organizational management REDCap is a client/server application that is accessed through an IP address and port. Intruders would first have to have access to the network then to the specific server, IP address, and port. Security is further enhanced as users are validated with a unique username and password combination. In addition before the user is logged in they must receive authorization.  LDAP can also be used to centrally manage users. The consortium partner is responsible for the reporting requirements in this requirement.
(e) Initial and periodic testing of devices, such as tokens or cards, that bear or generate identification code or password information to ensure that they function properly and have not been altered in an unauthorized manner REDCap does not support devices