1 Accessing REDCap

All HNRCA REDCap users must have completed their CITI training before accessing REDCap.

1.1 Logging in

HNRCA REDCap is available at: https://redcap.hnrc.tufts.edu/

You may access this site from anywhere and do not need to be on-site or connected to the VPN.

Your REDCap username and password are the same as your HNRCA credentials. During your first login, you will be prompted to set up two-step verification.

New REDCap users receive access instructions in the “Welcome to the HNRCA” email from Scientific Computing. If the REDCap link is missing from that email, contact your administrative coordinator to request access.

If you have trouble logging in, contact the REDCap administrator:

1.2 Requesting project access

Access to individual REDCap projects is granted separately.

To request access to specific projects, email the REDCap administrator at , and include the project name and your role on the study.

3 Entering Data

Many forms and events remain locked until prerequisite forms are completed.

3.1 Confirming the correct form

Before entering data, always verify:

  • Correct project
  • Correct HNRC ID
  • Correct event/visit
  • Correct form

This information appears at the top of the page.

3.2 Repeating forms

Some forms allow multiple instances per event. In these cases, a plus sign appears to the right of the status icon after the first instance is saved. Clicking the plus sign will take you to a new instance of that form where you can enter new data.

Once there are multiple instances of a form, the status icons will appear stacked.

3.3 Saving data

Data in a form are not saved automatically.

Available save options:

Save & Exit Form - saves and return to the Record Home Page

Save & Stay - saves and remains on the form

Save & Go To Next Form - saves and opens the next form (in other words, you’ll be taken to the next form for that record at that event (visit))

Cancel - discards changes and returns to the Record Home Page

3.4 Data resolution workflow

Any change to saved data requires documentation.

Click the comment icon () next to a field to open the Data Resolution Workflow.

In the popup, you can:

  • Verify data by selecting Verified data value and adding a comment. Note that the new data value must be saved in the form prior to verifying.
  • Open a query to explain or request clarification. The query can be assigned to another user (optional).

All data queries can be viewed by clicking the link under the ‘Applications’ section.

Clicking the history icon displays the complete audit trail for that field.

REDCap logs all data changes, including user, timestamp, and previous values.

3.5 Re-doing a visit

If a visit must be completely redone:

  1. Email the REDCap administrator before beginning a new visit
  2. Existing visit data will be removed (and retained in the audit trail)
  3. New consents and visit data may then be entered normally

4 Guidance on Common Forms

4.1 General form

Stores basic participant information, including first and last name, date of birth, email, address, etc. This form must be marked ‘Complete’ to unlock other subject info forms and screening forms.

4.2 Study Status

The Study Status form is a repeating instrument used to track the status of a participant in the study. It is typically kept up to date by the study coordinator. When entering a new study status, select the plus sign next to the icon to create a new instance. Existing study status forms should not be changed.

4.3 Progress Notes

The Progress Notes form is a repeating instrument used to add notes and associated documents (using the Upload file link) for a selected record. When a new document is uploaded and the form saved, the document will be embedded into the ‘Associated document’ field and will be accessible anytime this instance is opened.

If the ‘Send alert E-mail to’ field is completed, saving the form will trigger an email to the MRU staff or MD.

4.4 Randomization

The Randomization form becomes accessible once the participant has been signed in (MS Disposition set to ‘Accept’ and MD signature on the MD Sign in form).

4.6 NEL Labs

The NEL Labs form is used to store a PDF of the NEL Report and a confirmation that lab results letter was sent to the participant. When the Lab results letter sent to participant? field is completed with ‘Yes’, a new field will appear to upload a copy of that letter.

4.7 MD Sign-in

The MD Sign-in form is used to record the qualifications of a participant and to complete the MD review.

Scans of the screening orders and the study orders can be found at the top of the form. These are uploaded during project development.

Below the scans are qualification fields, filled out by nursing staff. The RN and RD can leave recommendations and comments if applicable.

Selecting ‘Yes’ in the Submit for MD review? field will trigger an email notifying the MD that a participant is ready for sign-in. All fields below this are grayed out and can only be used by the MD.

When a disposition has been logged (accept or reject) and the MD has signed the form, an email will be triggered to the DAU to notify that a new disposition is ready to be viewed.

If a participant is not submitted for MD review (‘No’ selected for Submit for MD review? by the nursing staff) or is rejected by the MD (MD Disposition set to ‘Reject’), an email will be triggered to the DAU to notify of the rejection.

5 eConsenting

5.2 eConsenting process

Once the consent survey is open on the iPad, follow all standard consenting procedures as described in the Record of Consent form.

Note that the Record of Consent form is a repeating form and a new copy should be filled out for each consent performed.

After reviewing the consent with the participant:

  1. Scroll to the “Documentation of Consent” section located below the consent PDF.
  2. Complete the required date, time, and signature fields
    • Use the ‘Today’ or ‘Now’ buttons to automatically populate the current date and time.
    • To add signatures, click the Add Signature link and sign in the displayed signature box (touchscreen devices are preferred).
  3. Click the Next Page >> button at the bottom of the form.

The following page will display a preview of the signed consent document. After reviewing the document, the participant will need to check the box stating that the information in the document is correct. After that they may press Submit.

This will save the consent form information, add a PDF copy of the consent to the Consent form in REDCap, and proceed to the next consent if applicable.

5.2.1 Printing a copy of eConsent form

To print a copy of the consent form for the participant:

  • Open the participant’s Consent form
  • Click on the PDF link in the Signed consent PDF field to download a copy

For older projects that have not been updated with file upload field in the consent form, a PDF copy of the consent will be saved to the File Repository after the survey is complete. To print a copy of the consent for the participant, navigate to the File Repository by clicking the link in the left-hand sidebar of the project in the ‘Applications’ section. From there you will see a folder called ‘PDF Survey Archive’.

5.3 Paper consenting

If for any reason eConsenting is not available or appropriate, you may default to a paper consent. To log a paper consent in REDCap, follow these steps:

  1. After completing the consent, scan the consent document to make a PDF copy.
  2. In the document name, include the subject’s name, HNRC ID, and the date and type of consent.
  3. Navigate to the associated Consent form and, in the Signed consent PDF field, click ‘Upload file’. In the pop-up, choose the file to upload and then click ‘Upload file’.
  4. Below the upload field, there is a General comments field. Enter a comment indicating that the consent was filled out on paper, and include your name and date to certify that the copy is an exact replica of the original document (all pages have been scanned and are legible).
  5. Scroll to the bottom of the consent form and mark the form status as ‘Complete’, then save the form.
  6. This constitutes source document transfer and thus you may now destroy the original document.

For older projects that have not been updated with file upload field in the consent form, follow these steps:

  1. After completing the consent, scan the consent document to make a PDF copy.
  2. In the document name, include the subject’s name, HNRC ID, and the date and type of consent. It must be descriptive as files are not separated by subject.
  3. Navigate to the File Repository and click the ‘Paper Consents’ folder. If the folder does not exist, create a new one by clicking the Create folder button.
  4. Either drag the file into the drag and drop area at the top of the page, or click the Select files to upload button and navigate to the consent PDF.
  5. Navigate to the subject’s associated consent form. Near the top of the form there will be a comment field. Enter a note indicating that the consent was filled out in paper and include your name and date.
  6. Scroll to the bottom of the consent form and mark the form status as ‘Complete’, then save the form.
  7. This constitutes source document transfer and thus you may now destroy the original document.

5.4 Downloading Consents

To download a copy of a completed consent, navigate to the associated Consent form and, in the Signed consent PDF field, click the link to the PDF file.

For older projects that have not been updated with this filed upload field, the completed consents can be downloaded from the File Repository.

6 Additional Resources & Help

At the bottom of the left-hand sidebar of every project are the Project Bookmarks and the Help & Information sections.

The Project Bookmarks section has links to this REDCap user guide and to Protocol Manager (PM). Both links open in a new window.

The Help & Information section has links to training videos and general FAQs from REDCap. It also has a link to contact the REDCap administrator by email.