HNRCA REDCap User Guide

1 Accessing REDCap

All HNRCA REDCap users must have completed their CITI training.

1.1 Logging in

To login to HNRCA’s REDCap, go to the following address in your web browser: https://redcap.hnrc.tufts.edu/ . Your login details will be the same as your HNRCA login credentials. This page is accessible via the internet, so you do not need to be in the building or connected to the VPN.

New REDCap users will receive a link for REDCap and instructions on how to access in the new employee ‘Welcome to the HNRCA’ email from Scientific Computing. If the REDCap link is missing from the email, contact your admin coordinator to request access. An initial log in, including setting up two-step verification, should be done using your HNRCA credentials at https://redcap.hnrc.tufts.edu/ .

If you have trouble logging in, please contact the REDCap administrator redcap@hnrc.tufts.edu .

1.2 Requesting project access

To request access to specific projects, send a request to the REDCap administrator redcap@hnrc.tufts.edu.

2 Navigating Projects

In REDCap, all the data associated with any given study can be found within a project. Within each project, participant data are contained in records. Records are generally linked to an HRNC ID. Data within a record are organized into instruments, which are commonly referred to as forms. Within any given form, individual data points are stored in a field. Fields can also be referred to as variables.

2.1 My Projects page

Once you’ve logged into REDCap, you’ll be greeted with the My Projects page. This page contains a list of all the projects you have access to.

You can sort the projects by clicking any of the table headers (eg ‘Project Title’) or by clicking the Organize button above the table to create folders and add your projects to them.

The last column of the projects table indicates the status of a project:

Development means that the project is still being revised and not yet ready for (real) data entry. Dummy data can be entered in this stage – this data will not carry over when moved into production.

Production means that the project has been finalized and is ready for entry of participant data.

2.2 Left-hand side bar

Once you have selected a project, you will be taken to that project’s home page. The project can be navigated via the links in the left-hand side bar. At the top of the left-hand side bar is My Projects link to return to your projects page.

The primary pages for accessing project data are in the ‘Data Collection’ and ‘Reports’ sections of the side bar. The ‘Data Collection’ section contains links to view, add, and/or edit project data depending on your user permissions. The Record Status Dashboard link displays a table of all project data (with optional filters) and the View / Edit Records or Add / Edit Records link is used for navigating to individual records. Reports are subsets of the project data meant for easy viewing. The ‘Reports’ section contains links to all available reports.

Note that the current project status is listed at the bottom of the ‘Project Home and Design’ section.

2.3 REDCap Tables

REDCap tables are used to organize project data and to access specific forms during data entry. These tables are found on both the Record Home Pages and the Record Status Dashboard.

2.3.1 Status icons

In REDCap tables, round icons represent data forms. These icons are clickable, and link to that particular form for data entry. The colors of the icons reflect the completion status for that specific form or set of forms for a repeating instance. All REDCap table icons follow the same color scheme and a legend describing the status colors is displayed at the top right of any page with a table.

If no data has been entered into the form, the icon will be gray. If data has been entered into the form, the icon will be red (incomplete), yellow (unverified), or green (complete).

A repeating form may contain multiple instances and is represented by a stack of icons. The icon for a repeating form will appear blue if one or multiple instances have different statuses. If all of the instances within a repeating form share the same status, the icon will follow the usual coloring scheme for incomplete (red), unverified (yellow), or complete (green) statuses.

A form’s status is controlled manually by a special field at the end of every form. It is up to the users entering the data to the set the status of a form.

Note that the unverified status indicates that there has been an automated data import into a form and should not be used in other situations.

2.3.2 Table scrolling

By default, tables are ‘floating’ and contain their own set of scroll bars, separate from the main page/browser scroll bars. If you find this cumbersome, you can click the gray Table not displaying properly link just above the table on the right-hand side. This will embed the table into the page so it does not have separate scroll bars.

2.4 Locating Record Data

2.4.1 Viewing all records for a project

To view all study data in a single table, you access the Record Status Dashboard by clicking the Record Status Dashboard link in the left-hand pane.

Each row displays a record (listed in the HNRC ID column) and each column a form/event combination.

If you would like to go into a particular data form, simply click the status icon associated with the record, event, and form you’re interested in. If you would like to view a Record Home Page for a participant, you can click the HNRC ID number in the first column. If you have create records privileges, you will also see a box above the table where you can enter a new HNRC ID number to create a new record.

The displayed records can be filtered by selecting an option under the Dashboard displayed dropdown. Additional custom dashboards can be requested from the REDCap administrator if needed.

Every project will contain a dummy ID 99999, used for project set up and testing. Real data should never be entered into this record.

2.4.2 Finding individual records

Navigate to the Add / Edit Records or View / Edit Records in the left-hand sidebar of your project.

This link may appear differently depending on your permissions within the project. For example, if you don’t have permissions to create new records this link will be displayed as View / Edit Records.

If you have the HNRC ID, choose the HNRC ID from the drop-down in the Choose an existing HNRC ID field. Once the drop-down is selected, you may begin typing the ID number to quickly jump to it in the list.

If you have create records privileges, another way to access a record is to search in the Enter a new or existing HNRC ID. This box will offer suggestions from existing IDs as you type, or you can enter a new ID.

Both options will open the Record Home Page, which displays a table of all of the data entered for the selected participant. Each row of the table represents a data form, listed in the first column, and each column represents an event, listed in the column headings. To access a data form, simply click on the status icon in the table corresponding to the form and visit you’re interested in. Additionally, any repeat forms (with data) will be listed below the table.

If instead of searching my HNRC ID you need to search by name or other participant information, you can use the ‘Data Search’ section of the Add / Edit Records page. If desired, you can select a specific field within the project to search. However, generally this is unnecessary and you can simply enter information into the Search query box. As you type, results will be displayed in a drop-down menu.

Clicking any of the results links will take you to the specific form and event where that data was found. For example, if you are searching by name and names were collected at screening in the visit information form, that is where you’ll be taken.

From a form page, the left-hand side bar will provide links for other forms within that event so that you can easily step through filling out information for a subject. Additionally, the ID number will be displayed above the form links. Clicking the ID number will take you back to that record’s Home Page.

2.5 Reports

A set of standard reports are automatically generated for every project. These reports are linked in the left-hand side bar under ‘Reports’.

Clicking on a report name will open the ‘Data Exports, Reports, and Stats’ page. Here, you can view the results of the report. At the top of the page, you can print the report or you can click Stats & Charts to view automatically generated plots and stats.

To request a custom report, contact the REDCap administrator.

3 Entering Data

Some forms contain text in red, which are reminders or warnings intended for the person entering the data.

The status of a form (status icons) is controlled by the last field in a form. This must be set to ‘Complete’ to unlock certain hidden forms/event if applicable.

3.1 Ensuring the form is correct

The most important thing to do before ever entering data into a form is to check and make sure that the form you have open is for the correct HNRC ID, the correct event/visit, and the correct project. This information can all be found at the top of the page.

The name of the project is displayed at the top of the page, while the HNRC ID and event/visit name are displayed at the top of the form. Often, participant names are displayed at the top of the form as well to help reduce confusion.

Beyond being on the correct form, you’ll of course always want to take care to ensure that you’ve selected the corrected field for any given data point. Generally speaking, fields are horizontally aligned with their labels and there are thin, gray lines separating each field.

3.2 Repeating forms

Some forms can have more than one instance per event. In these cases, once data has been entered into a form, a plus sign will appear to the right of status icon . 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. Clicking the icon stack will display a list of all of the form instances. Furthermore, once you’ve clicked on a form, there will be a Current instance drop down at the top of the page which allows you to switch between instances or create a new one.

3.3 Saving data

Once you’ve entered data into a form, you’ll want to make sure you save that form. The data entered is not saved until a save option is selected.

There are several save options presented at the bottom of each form as well as floating save options at the top right of the window:

Save & Exit Form will save the data and return you to the record’s Home Page.

Save & Stay will save the data and keep you on the current page.

Save & Go To Next Form will save and advance you to the next form on the list in the left-hand side bar. In other words, you’ll be taken to the next form for that record at that event (visit).

Cancel will remove any changes and return you to record’s Home Page.

3.4 Data resolution workflow

If for any reason data already saved in a field needs to be changed, a comment describing the reason for the change must be added. This can be done by opening a data query or verifying the data field. Both of these options are accessed by clicking on the gray comment icon next to any field. This will open a data resolution workflow pop-up.

Data can be verified by selecting Verified data value and leaving a comment. Note that the new data value must be saved in the form prior to verifying. After being verified, if that data value is changed, it will automatically become de-verified.

A new query can be opened by selecting Open query and adding a descriptive comment. The query can be assigned to another user (optional). All data queries for a project can be accessed by clicking the link under the ‘Applications’ section of the left-hand side bar.

Clicking on the history icon display the history of all the data that has previously been entered in that field (audit trail).

3.5 Re-doing a visit

When a visit has to be completely redone, an email should be sent to the REDCap administrator (redcap@hnrc.tufts.edu) before beginning a new visit. The current data for the visit will be removed by the administrator (while still being retained in the audit trail for compliance). It is then possible to obtain new consents and login the visit information as usual into REDCap.

4 Guidance on Common Forms

4.1 General form

The General form is used to record basic participant information, including first and last name, date of birth, email, address, etc. This form must be set to ‘Complete’ in order 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 is 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

5.1 Accessing consents

5.1.1 Preferred method

For studies with eConsenting (required IRB approval), the Consent forms will appear alongside other forms in the Record Status Dashboard and record Home Pages. To consent a subject, you’ll need to open the associated survey on an iPad. To do this, click into the consent form then from the Survey Options drop-down at the top select Survey Access Code + QR Code.

This will display a pop-up with the URL to navigate to on the iPad (https://redcap.hnrc.tufts.edu/surveys/). There will also be a direct link to this page on the iPad, which will be an icon called ‘Redcap Surveys’. You’ll also see a code, which should be entered into the iPad once the survey link is opened. You may also click Generate Short Code at the bottom to create a temporary shorter code. Entering the code will take you directly to the associated survey. You do not need to login to REDCap or navigate to the associated record.

5.1.2 Fallback method

If you only have a single device with you when performing a consent (ie. the iPad), the above method may not be feasible. As an alternative, you may access the consent by opening the REDCap link on the iPad, logging in, and navigating to the appropriate consent form as usual. However, rather than selecting Survey Access Code + QR Code from the Survey Options drop-down, you’ll want to select Log out + Open Survey.

If using this method, it is critical that you log out prior to handing a participant the device. In addition, when logging in to REDCap on an iPad or other public device, your password should not be saved.

5.2 Consenting process

Once the consent survey is open on the iPad, follow all normal consenting procedures as described in the Record of Consent form. 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, the survey will contain the appropriate date, time, and signature fields that must be filled out. For the date and time fields, the ‘Today’ or ‘Now’ button next to the field may be used to quickly fill in the current date or time. To add signatures, click the Add Signature link and sign in the displayed signature box. This is preferably done on an iPad or other touchscreen device. Once these items are filled in, click the Next Page >> button at the bottom of the form.

The following page will show a preview of the signed consent document for the subject to review. After double checking the document, the subject 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. To print a copy of the consent for the participant, navigate to the Consent form for the participant and download the pdf in the Signed consent PDF field.

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 side bar 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:

After completing the consent, scan the consent document to make a PDF copy.
In the document name, include the subject’s name, HNRC ID, and the date and type of consent.
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’.
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).
Scroll to the bottom of the consent form and mark the form status as ‘Complete’, then save the form.
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:

After completing the consent, scan the consent document to make a PDF copy.
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.
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.
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.
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.
Scroll to the bottom of the consent form and mark the form status as ‘Complete’, then save the form.
This constitutes source document transfer and thus you may now destroy the original document.

6 Additional Resources & Help

At the bottom of the left-hand side bar 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.