The following checklist is a general guide. Some steps may vary by institution. Follow your institutional-specific policy and procedures.
| Step | Completion | Task |
| 1 | ❏ | Contact Help-REDCap@bmi.cchmc.org and request a new project with the eConsent Template REDCap Project ID: ______________ |
| 2 | ❏ | Edit Informed Consent Form instrument (either create in REDCap OR cut and paste from word) |
| 3 | ❏ | Tailor signature section to protocol (i.e. add parent or assent if needed) |
| 4 | ❏ | Add optional choice fields (ex. sub-category agreement boxes such as consent for additional contact) |
| 5 | ❏ | Enable as survey |
| 6 | ❏ | Customize survey instructions section |
| 7 | ❏ | Customize theme to include institutional logo |
| 8 | ❏ | Turn on eConsent framework |
| 9 | Set-up email confirmation with a copy of PDF | |
| ❏ | If one Instrument: Enable confirmation email in survey settings with a copy of PDF | |
| ❏ | If multiple Instruments (consent & assent): Create Alert in the Alerts and Notifications Module. | |
| 10 | Is an additional consent or assent form needed? | |
| ❏ | If yes, Copy the consent instrument and edit as above | |
| ❏ | If no, go to the next step | |
| 11 | Decide how the participant will get to the consent | |
| ❏ | Research Staff invites specific participant: Edit landing page Keep as a Data Form Participant contact information (For Remote Consent) Add Variable to trigger an auto-invite email for a consent form to the participant. Go to the next step | |
| ❏ | Public link from website/flyer: Edit landing page Enable Survey Welcome message. Prep people for basic interest in the study and set expectations for consent. Collect contact information for REDCap's auto management. Skip the next step. | |
| 12 | ❏ | Enable ASI for consent. Place conditional logic with the trigger on the landing page. |
| 13 | ❏ | Customize Process Note: Add or remove process notes according to protocols informed consent process. |
| 14 | Create alerts & notifications | |
| ❏ | Alert for sending consent to the research team and Health Information Management (HIM) with conditional logic attached to process note | |
| ❏ | If virtual, Alert for study staff to complete process note | |
| 15 | Set-up participant movement post consent | |
| ❏ | Survey Queue | |
| ❏ | Separate Database | |
| ❏ | Directly into data collection | |
| ❏ | Payment and compensation forms (i.e. W-9) | |
| 16 | ❏ | Go back to project set-up and complete all boxes. (i.e. Set-up user rights, enable email, Twilio, repeating instruments, etc) |
| 17 | ❏ | Test |
| 18 | ❏ | Submit a copy of the Consent PDF to IRB for approval (Follow institutional eConsent policy. (CCHMC - Step not required UC - Check with your IRB representative) |
| 19 | ❏ | Place the database into production |
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