Surveys and eSignatures REDCapCON 2017 http://catalyst.harvard.edu

Overview eSignature Features: Field Type vs Record Locking Regulations Use Cases

Field Type = Signature (draw signatures with mouse or finger) eSignature Field Type Field Type = Signature (draw signatures with mouse or finger)

Displays on Data Collection Instruments eSignature Field Type Displays on Data Collection Instruments 1. Click Add Signature 2. Pop up Box Displays 3. Sign and Save 4. Image file is saved 5. Signature is displayed

eSignature Field Type Logging Note: subject_signature = ‘number’ This is the image file document number. This number will change when signatures are removed and re-executed.

eSignature Field Type Advantages: Can be on any form, including surveys Can have multiple signatures on a form/survey Can be signed by anyone No REDCap account needed Limitations: Is not “locked” to a record Changes can be made to data on form, signatures persists No data confirmation a person’s sig is executed by that person You must validate a PROCESS to confirm signature identity

E-signature - Record Locking Extension E-signature Record Locking Feature Requires: REDCap account User Rights Access > Locking/Unlocking with E-signature Authority Enable 'Record Locking Customization' > 'display E-signature option on instrument' to display E-signature on data entry forms

E-signature - Record Locking Extension 1. Check Checkbox for: Lock and E-Signature 2. Click Save 3. Pop up Box Displays 4. Enter username and password 5. Click Save

E-signature - Record Locking Extension Lock form: locked from editing E-signature and locking status is automatically date/time stamped E-signature details appear at the top of the data entry screens and on PDFs 8

E-signature - Record Locking Extension Unlock form: negates E-signature Changes can be made to the data entry form. Form will need to be re-signed (repeat E-signature Action)

E-signature - Record Locking Extension Logging

E-signature - Locking Customization Record Locking Customization: Assign E-signature meaning such as review, approval, responsibility, or authorship to designated forms When are E-signatures required? The FDA regulations (predicate rules, GxP) mandate when a regulated document needs to be signed. Study and protocol specific. 11

E-signature - Locking Management Summary view of Locked and E-signature Status for all forms Facilitates review process and end of study database lock and close 12

Regulations What documents are people signing? What are the Regulations: Enforcing Agency? Regulations will vary from country to county: US, EU, Canada, Mexico, Brazil, etc. EXAMPLE: US Clinical Trials / Protected Health Information -HIPAA: HHS Office for Civil Rights -21 CFR Part 11: FDA What do your IRBs / Legal Council advise? EXAMPLE: “REDCap is HIPAA compliant, but is not Part 11 compliant.  Our IRB does not view consent documents as source documentation that needs to be submitted to the FDA in compliance with Part 11 so this has not been an issue in terms of using e-consent.  However, many sponsors do apply Part 11 to the consent form and will require Part 11 compliance for electronic consent documents.  In those cases, electronic consent may not be appropriate for a study.” 13

Regulations - 21 CFR Part 11 In US, Title 21 Code of Federal Regulations governs Food and Drugs. Part 11 is the Food and Drug Administration (FDA) guidelines on electronic records and electronic signatures in the United States. Part 11 requires procedural controls (i.e. notification, training, SOPs, administration) and administrative controls in addition to the technical controls. REDCap “Compatible” with 21 CFR Part 11 At best, REDCap can offer an application containing the required technical requirements of a compliant system – the rest is up to the institution 14

Electronic Signatures - 21 CFR Part 11 Part 11.3: 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: Defined by E-Signature Action Electronic Record Part 11.3: 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. REDCap: E-Record is the form metadata + data entered + e-signature Signature/Record Linking Part 11.70: 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. REDCap: Record Locking Process 15

Electronic Signatures - 21 CFR Part 11 If your project is using e-signatures for 21 CFR Part 11 projects, the study personnel must adhere to the following requirements: Each electronic signature will be unique to one individual and will not be reused by, or reassigned to, anyone else. Before an electronic signature can be established, the study site will verify the identity of the individual. Persons using electronic signatures shall, prior to or at the time of use, certify to the agency that the electronic signatures in their system are intended to be the legally binding equivalent of traditional handwritten signatures. 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. Required: Handwritten Signature on file. This ensures the user agrees the E-Signature is equivalent to their handwritten signature and is legally binding. Recommended: EDC User Agreement 16

Electronic Signatures - 21 CFR Part 11 Part 11.50 Signature manifestations Signed e-records shall contain information associated with the signing that clearly indicates: (1) The printed name of the signer; (2) The date and time when the signature was executed; and (3) The meaning (such as review, approval, responsibility, or authorship) associated with the signature. 3 1, 2 17

Surveys & eSignatures Use Cases eConsent REDCap User Agreement Forms Examples collected from REDCap Community https://community.projectredcap.org/articles/24846/use-cases-needed-for-redcapcon-2017-breakout-sessi.html

Questions? Greg Neils Ralph Williams Senior Data Manager Chief Operating Officer Data Coordinating Center Access to Wholistic and Productive Living Institute Inc. Columbia University gn2003@cumc.columbia.edu rwilliams@awpli.org Lynn Simpson Riinu Ots, PhD Research Service Manager Data Manager Clinical Surgery Harvard Catalyst The University of Edinburgh Partners HealthCare R.Ots@ed.ac.uk lasimpson@partners.org 19