Table of Contents

Purpose

There are many types of informed consent docs / processes as outline on INFO: REDCap: eConsent / Paperless Consent

.

Mass General Brigham (MGB) has developed a REDCap eConsent Framework that will turn the paper-based participant consenting processes into an electronic consent process.  MGB has validated the REDCap eConsent Framework with respect to appropriate areas of compliance with internal requirements, health authority expectations and other regulatory requirements, including FDA 21 CFR Part 11. The final validation package consists of approved and executed plans, test scripts and test results, reports and supporting documentation; and is available to MGB researchers to provide to sponsors and auditors with appropriate agreements in place: REDCap eConsent: Compliance

.

This HOW TO document will help ensure that you are complying with MGB Policies and where applicable 21 CFR Part 11.

.

eConsent Training Video

https://opencourses.partners.org/course/view.phphttps://opencourses.partners.org/course/view.php?id=1906?id=1906&sectionid=7127

Informed Consent and Regulatory Requirements

Other Considerations:

If you have a specific question about this REDCap eConsent, please email redcap@mgb.org for assistance. 

REDCap eConsent Use Cases & Workflows

There is currently one template in REDCap that can be used and modified based on your eConsent Use Case and workflow.

Validated Use Cases	General Modifications to make to Template
Use Case 1: Subject/LAR approached in-person at an MGB clinic, accesses the REDCap survey via iPad or other portable electronic device. All consent stakeholders (Subject/LAR, study doctor, witness, interpreter) are available to sign at the same time.	Original eConsent Template was built on this Use Case and has since been modified. In this scenario, the consent participants / translators / witnesses will still sign the form in survey mode using “open as survey and logout” feature.
Use Case 2: Subject/LAR approached remotely (via phone, virtual meeting) and consent stakeholders (Subject/LAR, study doctor, witness, interpreter) are each sent an email to review and sign consent.	Included in Template.
Use Case 3: Subject Self-initiates access of consent forms on personal portable electronic devices using posted QR codes or web-links on study posters, brochures, or websites. Self-initiated accesses of consent forms may occur in clinic or at home.	This requires the Research Consent Form to be the first form in the project and have the Public Survey URL enabled. Participant Info (ex. Subject Name, DOB, MRN) would be moved to Research Consent Form and be collected directly from person signing consent.
LAR / Guardian signatures: (Other use case workflow additions) • The ability to include LAR to sign Consent for the subject • The ability for a subject to review LARs signed Consent PDF form and sign “Continuation of Consent” form	Included in Template. If LAR is not applicable to your study, delete out references to LAR and “Continuation of Consent” form
Witness: (Other use case workflow additions) The ability for a witness to sign	Included in Template. If witness is not applicable to your study, delete out references to witness
Children: (Other use case workflow additions)	You can include multiple types of consent forms on the Research Consent Form. Follow each Consent PDF with the required REDCap fields and signatures. Who will sign the Consent? The current Template includes Subject, LAR, and Assent choices. You can modify those choices to include the Age Groups. For example, one study listed the following: 1, Subject 2, Parent(s)/Guardian with verbal assent (6) 3, Parent(s)/Guardian and Assent (7 – 13) 4, Parent(s)/Guardian and Assent (14 – 17) Then you can branch the appropriate forms/fields to display based on age group. On the Research Consent Form, you can have multiple Consent forms and hide/display them + Questions + Signature fields using branching logic. Setup reports or notifications so the study staff can be notified when a child turns 7 and/or a child turns 18. Then the staff can initiate re-consent process as needed. Prior to any re-consent situation the study team must have a conversation with the adult/child regarding the reasons for the re-consent and to provide any additional information that may be necessary. An electronic consent should never be sent without prior conversation (i.e. do not program ASIs or Notifications & Alerts directly to participants to automatically send re-consent forms; only send notifications to study staff to initiate process).
Non-english Speakers: (Other use case workflow additions) The ability for short forms (multiple languages) and interpreter signatures / documentation See: E.MultilingualConsentOptions .	Included in Template. If short forms are not applicable to your study, delete out references to short forms. See the Research Navigator to download short forms in different languages. Upload a PDF version of the short forms or your fully translated consent form to the Research Consent form. Use branching logic to hide/display short forms or fully translated consent form. Obtaining and Documenting Informed Consent of Non-English Speakers When enrolling subjects who do not speak English in research, the subject must be provided with BOTH: • a written consent document in a language understandable to them, AND • an interpreter fluent in both English and the subject’s spoken language Depending upon the research, the written consent document can be either: • a written translation, in the subject’s language, of the entire English version of the consent form approved by the Partners Human Research Committee (PHRC), OR • a written translation of the so-called ‘short form’ consent document The ‘short form’ should generally only be used when the research involves no more than minimal risk to subjects or, if more than minimal risk, presents the prospect of direct benefit to individual subjects. The entire consent process must be witnessed by an individual who is fluent in both English and the language understandable to the subject. The interpreter may serve as the witness to the consent process (presentation of the information in the consent form in the language understandable to the subject and the opportunity to ask and receive answers to questions); • The PHRC-approved English version of the consent form must be signed by the investigator obtaining informed consent and the witness to the consent process (see 3 above); • The written translation of the ‘short form’ must be signed by the subject and the witness to the consent process (see 3 above); and • The subject must be given signed copies of both the PHRC-approved English version of the consent form and the written translation of the ‘short form’ consent document.
Other use case workflow additions: The flexibility to allow for different users: signer, study doctor, witness, interpreter; to sign remotely via survey and at different times.	Included in Template: Alerts and Notifications to automate email invites for signatures. To disable, navigate to the Alerts & Notifications and under options, select “Deactivate alert.”

HOW TO: Project Setup

A. Request a New Project using the project template: Electronic / Paperless Consent Template

Note: You should NOT create an eConsent project by copying an existing project. This will cause you to lose many settings that you would have to replicate on the copied project. Additionally, by using the most recent template, you are assured that you will get the latest eConsent features. 

B. Assigning User Rights within the Project

Two roles have been creating in the project to assist with assigning the correct level of access.

Project Manager – If you are building your project, you should assign yourself to this role. This will allow you to manage all aspects of the project including the e-Signature locking / unlocking settings

Investigator – You should assign study staff which will be consenting patients to this role. They will have the ability to create / modify records and to lock and provide e-Signature for the Confirmation of Consent Investigator form.

C. Customize the Data Collection Instruments

Where possible, items that will require your customization will be highlighted in yellow in the template

From the Project Setup page, click on “Online Designer” to customize the data collection instruments

Projects will typically have 2 – 5 instruments as follows:

Instrument 1 – Participant and Consent Information

This instrument consists of customized fields such as:

This instrument can be enabled as a survey. Advantage of NOT enabling as a survey is that you can disable auto-numbering and assign study specific subject IDs to each record. The Subject ID appears on the printed/PDF copy for each page of the consent form.

Shazam Fields: Allow you to enter one list of Investigators/People Obtaining Consent in the field (investigator_consent) with the format: code, Name Name (email) – and this will auto-fill the name and email fields separately for piping into forms and alerts. Do not modify the other 3 fields or the variable names – this will break the Shazam Code.

By selecting a drop down option, the Investigator Name and Investigator Email will be parsed to individual fields:

.

.

Consent Version (consent_version)

For a new project with the first version of the consent form, modify the option label “v1 Label” to the current version ID of your Consent form.

.

Instrument 2 – Research Consent Form

This instrument consists of a descriptive text field with the IRB Approved Consent Form, required fields to capture Subject/LAR’s signature and date of signature.

Customize as follows:

.

Instrument 3 & 4 – Confirmation of Consent

These instruments will allow you to collect signatures for Study Doctor, Witness, Interpreter.

Note: This has recently been updated to use the E-signature authority feature for Investigator sign off

Instructions for activating E-Signature authority for existing eConsent templated projects

Step	Screenshot
User Rights 1.Modify your own user rights to allow for “Record Locking Customization” and “Locking / Unlocking with E-signature authority” 2.Any investigator who will need to sign off on consents must also have the user rights for “Locking / Unlocking with E-signature authority” 3.We encourage you to create roles for investigator to make assigning user rights convenient
Modifying the E-Signature settings 1.Navigate to “Customize & Manage Locking/E-signatures” setting under the left applications menu 2.Ensure the “Confirmation of Consent Investigator” instrument has the following settings: 1.“Display the Lock option” item checked 2.“Display E-signature option on instrument?” item checked 3.“Lock Record Custom Text” has this wording: I certify that all the information entered is correct. I understand that selecting E-signature will electronically sign the form and that signing this form electronically is the equivalent of signing a physical document.
Modifying Alert #2 Modify the text in Alert #2 to link directly to the record within REDCap, not in survey mode:  Click link to confirm consent: [form-link:confirmation_of_consent_investigator] .

Instrument 5 – Signed Consent Copy

This instrument allows you to upload a PDF of the completed consent form to distribute to the participant. For email notifications: You must either enable the REDCap Survey Login feature or use SEND SECURE.

The Signed Consent Copy form is prevented from being opened until a signed consent form has been generated by the “Form Display Logic” tool. This will prevent users from inadvertently permanently deleting a compiled consent PDF by opening and saving the form with no value in that field. 

The logic for this display logic is: 

Form Display Logic Syntax

[signed_consent_form_copy]<>” or [signed_consent_copy_complete]<>0

.

The submit button is permanently hidden on this form. 

Survey Instructions Template Language:

Thank you for your participation in the research study:

Protocol Name
If you have any questions, please contact:
Site Principal Investigator: 
xxx-xxx-xxxx

Study Website

Please download the copy of your signed consent form below.

Note: Th

Instrument 6 – Continuation of Consent

Continuation of Consent instrument allows:

1) Subject to see a summary of LAR signed eConsent and sign consent to continue in the study.

2) “Continuation of Consent – Age 7” = Child turning 7 to provide assent

3) “Continuation of Consent – Age 18” = Child turning 18 to provide consent as an adult

This will allow for the original consent instrument to remain untouched and the new instrument(s) available in the same record with the same subject ID. You may need to program continuation of consent for study staff depending on signatures that are required for your study’s Continuation of Consent process.

Note: Prior to any re-consent situation the study team must have a conversation with the adult/child regarding the reasons for the re-consent and to provide any additional information that may be necessary. An electronic consent should never be sent without prior conversation.

Can be deleted if LARs/Assent/Subjects are not re-consenting for your protocol (this process is different than re-consent due to consent version changes. See below on how to make changes to consents  and consent versioning.

Instrument 7 – Consent Tracking

This template is from Research Navigator: QI Study Management Tools > Documentation of the Informed Consent Process Checklist Apr2020

Questions about this form can be directed to the MGB QI Program. To Note: Per policy a copy of the signed and dated informed consent must be uploaded to Epic if the study involves an intervention or treatment. It is best practice to upload all fully executed consents to Epic for safety reasons since there are blood draw limits, radiation exposure limits, as well as possible drug interaction issues.

If you are using the REDCap eConsent module then REDCap can be the electronic storage location for the fully executed consents. There should be no need to retain a paper copy if the consents are stored securely electronically in REDCap. If you have questions regarding recordkeeping requirements for research please contact the QI Program.

D. Customize Survey Settings: 

Where possible, items that will require your customization will be highlighted in yellow in the template

2. At minimum, add the Research Study Name, Investigator and Contact information to EACH survey’s Survey Instructions and Survey Completion Text.

Template for Thank You Survey Screen:

Thank you for your participation in the research study:

PROTOCOL NAME

If you have any questions, please contact:

Site Principal Investigator:

xxx-xxx-xxxx
Study Website Link

3. Survey Login is enabled for the Research Consent Form and Signed Consent Copy. This will require the Subject/LAR to enter the Subject DOB prior to accessing the Survey. You may opt to select other identifiers for the Subject/LAR to enter.  Survey Login Settings can be modified on the Online Designer page. 

.

4. Ensure either Auto-Archiver + e-Consent Framework OR the External Module: Survey eSignature Certification is enabled on each survey with signatures. 

When to use Auto-Archiver + e-Consent Framework vs External Module: Survey eSignature Certification

4a. Enable Auto-Archiver + e-Consent Framework on the Online Designer > Survey Settings page

Use the label feature to include Subject First Name, Last Name, MRN or DOB, on the PDF. Even though the Optional field is labelled as “Date of birth field” if you are using MRN instead, you can select that variable name.

4b. Enable the External Module: Survey eSignature Certification:

Configure Survey eSignature Certification for eConsent:

Once saved – the Survey eSignature Certification will display on the Online Designer > Survey Settings page instead of the Auto-Archiver + e-Consent Framework option.

.

E. Set/Edit PDF “Custom Record Labels”

In accordance with MGB IRB policies, the subject’s name and medical record number or date of birth should be recorded on each page of the informed consent documents. 

From the Project Setup page, click on “Additional Customizations”

The project template will automatically include the following: “[subject_firstname] [subject_lastname], [subject_dob]”

This ensures that the specified fields automatically display at the top of each informed consent document when downloaded as a PDF.

The labels can be updated to reference additional variables in your project or you could optionally edit the labels to look something like: “Subject Name: [subject_lastname], [subject_firstname] Subject DOB: [subject_dob]”

.

F. Create fully executed signed PDF – ONE Complete PDF form with all applicable signatures

AUTOMATED PDF GENERATION

Automated PDF generation of fully executed consents is performed by the Paper Trail external module. This module will combine multiple instruments into a single PDF document with the custom record label applied to the top of each page. 

External Module: Paper Trail

The template comes with two use cases pre-programmed. These configurations should be reviewed and can be modified. Additional use cases can be added. 

First use-case (Research Consent)
Description	Combines the participant and the clinician signatures into a pdf
Forms Combined	• research consent form • confirmation of consent investigator
Target upload field	signed_consent_copy
Triggering Fields	• consent_signature • obtainconsent_signature

Second use-case (Multilingual Consent using interpreter)
Description	Combines the participant, clinician, and interpreter instruments into a single pdf
Forms Combined	• research consent form • confirmation of consent investigator • confirmation of consent interpreter
Target upload field	signed_consent_copy
Triggering Fields	• consent_signature • obtainconsent_signature • language_signature

To Configure Paper Trail for Additional Use Cases

Additional use cases may include assents signatures, witnesses, and/or LARs. 

This example will instruct on how to add a Paper Trail use case for Confirmation of Consent Witness

.	.
External Module Settings • Navigate to external modules and configure the Paper Trail module
Add an additional Use Case • Select the + button next to Specify use-case and navigate down to the newly created use case.
Use-case Name • Give your use-case a descriptive name  .
Instrument Selection • Add all instruments that will need to be combined into a single PDF • Use the + buttons to add additional forms Note: All Instruments that should be combined MUST be enabled as surveys
Target Upload Field Selection • Select the file upload field you want your fully executed consent PDF to be stored in.  • The default field is “signed_consent_form_copy” • If using a longitudinal project, designate the event this field is in.  Note: The file upload field CANNOT be on any of the instruments being combined
Target Field Form Status • Select the instrument status you would like your target field’s to change to when a PDF is generated. • The default value is “Unverified”
Use Case File Prefix • This text will be applied to the file name of all generated PDFs using this use-case Note: This field should ONLY contain text. Do not add special characters like spaces or slashes.
Trigger Fields • Select the signature fields that must be completed to trigger this use-case .
Use Case Status • Set this use-case to “Active” when you are ready

.

Distribute the fully executed signed PDF to you study participant:

Example Email Text:

When the Subject/LAR clicks on the link, they will be taken to a REDCap Survey and prompted for their Survey Login (DOB):

New Feature: PDF Paper Trail Archive NEW FEATURE 

An improved PaperTrail external module has now been released. A new feature, the  PDF Paper Trail Archive, has been added to the module.

This item is now available under the “External Modules” section of the left side project menu.

This new tool will allow you to see all PaperTrail produced compiled PDF files and download them individually or all as a packaged file.

G. Multilingual Consent Options

External Module: Multilingual – v1.9.81+ DEPRECIATED

You now have the ability to display multiple languages in one project and display multiple languages for question/answer text which will save data to one variable. To enable this feature, navigate to the project Applications menu > External Modules. Click the green button to +Enable a Module and search for Multilingual. Instructions are provided in detail within the module documentation.

Note: In REDCAP v12 the new integrated MLM tool was released. This would be the tool to use multi-lingual settings.

eSignature Attestation Translation Options

If you are using the External Module: Multilingual v.1.9.8 you can translate the “certification box”, by modifying PDF Encodings/Translations > EConsent Checkbox Text

.

If you use the External Module: Survey eSignature Certification – v1.2, enable: Default attestation settings > User-Defined
-You can add both English and Spanish text here. We have this on our feature enhancement list to be more dynamic (only one language or the other).

In addition, we’ve requested help translating the both Attestation Text officially from MGB but no response. If you have any channels to help officially translate this language by MGB approved translators, please help us!

H. Alerts & Notifications Options

Where possible, items that will require your customization will be highlighted in yellow in the template

Alerts & Notifications are not required, but can be helpful to streamline your workflow. Setup Alerts and Notifications to automate notifications to study doctors, witnesses, interpreters when Subject/Lar has signed consent. Automatic Survey Invitations and Survey Notifications can also be used in your workflow.

A set of alerts is included in the project template. By default, these alerts are deactivated. To turn them on your will need to re-enable each individual alert.

Activating the Alerts

REDCap eConsent: Alerts and Notifications

Alerts and Notifications can be programmed to automate the sending of emails to Subject, LARS, Co-Is, Witnesses and Interpreters. If you use the template Alert and Notifications, you MUST change the “from” email no-reply@partners.org to your study group email or point of contact. Some email services are moving emails from no-reply to spam/junk folders OR blocking the email altogether.

Alert Example 1: After initial contact (phone, zoom), Emails are sent to Participant / LARS, inviting them to sign eConsent

Email Template Language:

From Email Address = Study Group Email or Site Investigators Email

Subject: eConsent for Research Study 

Dear Participant [Guardian or Authorized Representative],

Per your request, I’ve including a link to the electronic consent (eConsent) for participation in the research study as described during our telephone conversation. 

Research Consent Form [survey-link:research_consent_form]

If you have any questions, please contact me at xxx-xxx-xxxx 

Thank you,

Site Investigator’s Name

Alert Example 2: Once Subject/Lar signs consent, Co-Is, Witnesses, Interpreters can receive emails for signatures

Email Template Language:

From Email Address = Study Group Email or Site Investigators Email

Subject: Action Required: Confirmation of Consent

A consent form has been signed by Subject/Lar for (Protocol Name)

Click link to confirm consent: [form-link:confirmation_of_consent_investigator]

Note: This has been updated recently to use the e-Signature Locking / Authority Settings

Alert Example 3: Once all required signatures are obtained, Emails are sent to Participant / LARS, to distribute signed copy of eConsent

Email Template Language:

From Email Address = Study Group Email or Site Investigators Email

Subject: Copy of Research eConsent

Dear Research Participant,

A copy of your voluntary research consent can be obtained by following the link:

Signed Consent Copy [survey-link:signed_consent_copy]

If you have any questions, please contact me at xxx-xxx-xxxx 

Thank you,

Site Investigator’s Name

.

HOWTO: Test your project.

**It is CRITICAL that you enter data for your project. This is the only way to test the workflow and for REDCap Admins to review your eConsent setup is correct prior to moving to production (see below).

All features (surveys, email alerts) work the same in development as they do in production. Please test by entering your email into subject_email / lar_email fields to see how the alerts and the surveys work. You can also open surveys by adding new records, navigating to the surveys and opening via Survey Options (top right on forms enabled as surveys). 

Testing Procedure Step	Screenshot
A. Create the participant record 1.Select ‘Add/Edit Records’ 2.Enter in a new or existing Subject Identification and press enter 3.Enter data on the Participant and Consent Information form. 4.Select ‘Complete’ for form status 5.Click ‘Save & Go to Next Form’
B.  Access record-specific Research Consent Form as a survey and submit 1.Click on the “Survey Options” menu in the upper right corner 1.Note: You must enter the consent form from the ‘Participant Information’ form to trigger the ‘Survey Options’ feature. 2.Select ‘Log out + Open Survey’ to open the consent form in survey mode 3.Complete the consent document  ◦ Enter all needed data on your form ◦ Sign and initial in the signature field(s) using the “Add Signature” button ◦ Click ‘Today’ in the date field(s) 4.Click ‘Submit’ at the bottom of the consent survey to register the consent document into the record – Confirm signature attestation screen/pop-up appears to certify signatures.
C.  Access record-specific Confirmation of Consent(s) as survey/forms and submit Once the Research Consent is saved to REDCap, complete applicable study doctor, witness and/or interpreter forms/surveys: • Sign their name in the signature field • Click ‘Today’ by the date field • Submit and certify signatures	.
D.  Confirm Creation of Fully Execute Signed PDF  At the end of the REDCap process, ONE fully executed signed PDF with the Stamped IRB Approved ICF PDF + Subject/Lar Signatures + Study Staff Signatures are required. • Confirm fully executed signed PDF is in REDCap’s File Repository > PDF Survey Archive • Confirm Fully executed signed PDF has the Name and (MRN or DOB) on each page of the ICF • Confirm Audit Trail demonstrates Study Participant actions differently than Study Staff actions.	.
E. Request the Move project to production status. REDCap Admins will review the following items in your project to evaluate if your eConsent is properly configured: 1.Check the IRB Approved Consent forms display and the REDCap fields match the consent form fields exactly 2.Check that either the Auto-Archiver + e-Consent Framework or Survey eSignature Certification is enabled 3.Check External Modules Survey eSignature Certificate and Paper Trail (if using) are configured correctly 4.Check that test data is entered 5.Check that the fully executed signed PDF is in the File Repository > PDF Survey Archive 6.Check that the fully executed signed PDF has the Name and (MRN or DOB) on each page of the ICF *Workflow (alerts, email communications, order of signatures) vary from project to project. REDCap Admins may ask about your workflow to clarify eConsent process, but are not testing or reviewing those features. It is on the study team to test all workflows. A REDCap Admin moving the project to production does not indicate the project complies with IRB/QI requirements.	.
.	.

What to check to ensure your project is functioning correctly

Compliance

Does your compiled executed consent contain the following?

Does your project log reflect the following?

The email address for the consent event matches the participant information

.

.

HOW TO: Make Changes / Amendments to Consent Forms

Versioning the Consent Form

Participant And Consent Information Instrument

Step	Screenshot
1.Update the consent_version field by adding a new choice for consent version. You must maintain the same raw/label values for previous consent versions 2.Update the consent_version field @DEFAULT action tag to reference the new option 3.Add a @HIDECHOICE action tag to hide the previous version

.

Research Consent Form

Step	Screenshot
1.Copy the existing consent_pdf field using the “copy field” tool
2. Modify the new field by updating the label to reflect the new version 3. Modify the new field by removing the PDF and adding in your new version *REMINDER: This file must be a PDF
4. Modify the branching logic for your new field to display when the appropriate version has been selected in the “Participant and Consent Information” has been selected.

Consent Versioning FAQ:

Q: If I replace the current PDF consent version to use the most recent consent version, will it change the PDF consent version being displayed on previous records?

A: YES, this is why you must ADD a new Descriptive Text field with file upload for the new version instead of replacing the current consent PDF version.

You must keep all existing versions to ensure correct version tracking for previous records.

Q: Do we need to use branching logic to point to each approved consent form?

A: YES, by having a consent version field on the Participant and Consent Info form, it allows you to designate which version should display to the participant. By using the @Default action tag, it will prefill for each new record the correct required version.

VERY IMPORTANT NOTE about RECONSENT 

***If you need to reconsent participants: currently, you must add a NEW project Record to reconsent a participant. Labelled something like RECORD01-RC1*** This is because you will need to maintain the original record as is  and ensure data is available for review.  Right now, PaperTrail is limited to non-longitudinal projects.

Contact REDCap support for help with versioning if you are having difficulty!

FAQs

Q: Can eConsent be included with project data?

A: It can, but may not be optimal. We discourage you from including project data in your eConsent project. This can cause issues with re-consenting patients and/or regulatory compliance.

Limitations TO NOTE:

There is no requirement that the ICF is maintained with other subject-specific CRFs, although it is convenient and the usual practice.  When a team maintains paper files for a protocol, there are typically the regulatory binders for the essential documents and individual subject binders for all subject-specific forms. Generally the signed and dated informed consents are maintained in the subject files along with other CRFs such as the Demographic, Eligibility, AE Log, Con Med Log, Drug/Device Accountability, Lab Reports, Procedures Reports, Study Visit Notes, etc.  Anyone on the IRB-approved study staff list has the right to see identifiers as do regulatory inspectors, monitors, and auditors.  User Rights in REDCap gives the team adequate control of access to identifiers.

Q: If I have an existing REDCap project collecting study data, how do I add the eConsent template/forms?

If you want to add eConsent Workflow to an existing REDCap project already in production and actively collecting study data, it is best to copy your current study project and use this copy to configure and test so you do not disrupt current data collection. 

Items to consider:

In the (new) copy/test project, you will need to:

Then you can export the desired instrument zip files from your test/dev project and add them into your production project via DRAFT MODE. After the forms are added into your production study project, you will then need to add in the additional configurations (see below: items to consider).

Instrument Name	Zip File	After adding in to project:
Participant and Consent Information	ParticipantAndConsent.zip	Request Shazam be Enabled
Research Consent Form	ResearchConsentForm.zip	Enable as a Survey
Confirmation of Consent	ConfirmationOfConsentInvestigator.zip ConfirmationOfConsentInterpreter.zip ConfirmationOfConsentWitness.zip	Enable as Surveys
Signed Consent Copy	SignedConsentCopy.zip	Enable as a Survey
Continuation of Consent	ContinuationOfConsent.zip	Enable as a Survey
Consent Tracking	ConsentTracking.zip	.

.

Q: Is their a way to remove the subject ID from the consent header?  We are required to upload ICFs to EPIC and do not want the “link” between subject ID # and name easily accessible to non-study staff.

Typically, the subject ID is not on the paper ICFs, although some study teams do include the study ID.  When study teams enroll their subjects in a study in Epic, they often include the study ID number in the enrollment so when QI runs an enrollment report from Epic, they get the list of subjects with their MRNs, date of Epic enrollment, enrollment status, and participant ID.  So the key to the code is often already in Epic in the study enrollment section.   

Epic is a secure system and only individuals authorized to use Epic have access.  All users must log in with their username and password, activity in the system is tracked, and per policy users must only look at what they are entitled to look at adhering to the minimum necessary standard.  In addition, all employees sign a confidentiality statement annually.  As such the key to the code linking study ID to the subject is still being maintained securely.   

If you have additional questions or concerns, please contact MGB Human Research Quality Improvement Program at humanresearchqi@partners.org

Additional Best Practices

Create a study folder in REDCap to group your study’s databases/projects

1.  Create the study folder

2.  Assign study projects to the folder

Changelog and Updates

2023-11-04

2023-05-14

2023-01-10

2022-06-23

Per the guidance of the IRB, the eConsent template has been updated to use the record locking / e-Signature features in REDCap for the Confirmation Of Consent Investigator instrument. This change will have the following impacts:

Related

Save

Save

Save

Save

Save

Save

Save

.

.