A subject exists in the study before they have an eCRF. Adding them and including them are two separate actions, and the words for them are easy to confuse. This article covers both, and what each one means.
🔑 Prerequisite: eCRF Record List (Access, Add). The eCRF must be published and the study set to Live before you include real subjects, and the study must have at least one center.
Two places to add a subject, and they offer different options
Getting these straight saves a lot of confusion, because the two windows look similar and do not offer the same things.
From | Window | Your options |
Subjects page, blue + | Add subject in the study | From database, From recruitment, or New subject |
eCRF > Inclusions list, + New Participant | Create New Participant/Subject | New subject, or Subject in the Study |
New subject: someone who does not exist on your instance yet.
From database: someone already in your Subject Database. This is a separate module, so the tab is only useful if your plan includes it.
From recruitment: someone who applied through a recruitment study on your Site CTMS and has reached Qualified or Enrolled. See Include a participant recruited through the Site CTMS below.
Subject in the Study: someone already added to this study on its Subjects page, whose eCRF has not been created yet.
From database and Subject in the Study are not the same thing. The first reaches into another module. The second only lists people already attached to this study.
Add a subject from the Subjects page
🛠️ Step by step guide
Open the study and go to Subjects.
Click the blue + at the top left. The Add subject in the study window opens.
Choose your tab: New subject to create someone, From database to search your Subject Database, or From recruitment to take someone from a linked recruitment study.
Complete the fields. On the From database tab you can search by Platform ID, first name or last name.
Choose the Center name. It is required here.
Click Add.
⚠️ Warning: if the study is still in Draft, the window shows a yellow banner reading "Your study is currently in draft mode. Please add only test subjects. In draft mode, all subjects added will automatically be deleted and no longer available when the study goes live." Take it literally. Never record real participant data before the study is Live.
Include the subject in the eCRF
Adding a subject does not create their eCRF. Until you include them, their eCRF tab reads Subject is not included in the study.
🛠️ Step by step guide
Open the study and go to Subjects.
Select the subject in the list on the left.
Open the eCRF tab.
Click Include subject.
💡 Tip: the eCRF is created and connected to the subject automatically, and opens on the first form. The subject page is also where you find the fields you will be asked about later: email, phone, account status with a Resend link for the invitation, center, creation date, Subject ID and Randomization ID. The ePRO, eConsent and Documents tabs work the same way for those modules.
Include a participant recruited through the Site CTMS
If you recruit through a recruitment study, the two studies can be connected so participants move from screening straight into the eCRF without being retyped. That is what stops the same person existing twice on your instance.
🔑 Prerequisite: three things must all be true, and they are set in three different places.
The recruitment study status is Recruiting.
The EDC study status is Live.
The recruitment study's settings carry an EDC link pointing at this EDC study.
Once those are in place, the route is the same as any other subject on the Subjects page.
🛠️ Step by step guide
Open the EDC study and go to Subjects.
Click the blue + and choose the From recruitment tab.
Find the participant. Only participants who have reached Qualified or Enrolled in the linked recruitment study appear here.
Choose the Center name.
Click Add, then include them from their eCRF tab as above.
⚠️ Warning: if the From recruitment tab shows nobody, work through the three prerequisites in that order. The usual cause is the EDC link never having been set, and it lives in the recruitment study's settings, so someone working on the EDC side cannot see it or fix it themselves. The second most common cause is that the participant has not yet reached Qualified or Enrolled.
Add and include in one action, from the Inclusions list
Working from the eCRF rather than from the subject, the Inclusions list does both steps at once.
🛠️ Step by step guide
Open the study and go to eCRF > Inclusions list.
Select + New Participant. The Create New Participant/Subject window opens.
Choose New subject to create someone, or Subject in the Study to include someone already added to this study.
Complete the fields. Center name is optional here.
Click Add.
💡 Tips
The subject and their eCRF are created together, and the eCRF opens on the first form.
Center name is required on the Subjects page and optional here. If your study reports by center, fill it in either way.
There is no From recruitment tab in this window. To take someone from a recruitment study, use the Subjects page.
If you cannot include a subject
Two different things cause this, and they look the same from where you are sitting. You can tell them apart with one test: try to add the same subject from the Subjects page instead.
What happens | What it means, and what to do |
Neither route works. You cannot add from the Inclusions list, and you cannot from the Subjects page either. | This is a permission, not a setting. You need eCRF Record List (Access, Add). Ask whoever manages roles on your instance to add it to your role. |
The Subjects page works, and it asks you to type the Subject ID yourself. | Your study is configured so that subject IDs are typed by hand rather than generated. A hand-typed ID can only be entered from the Subjects page, so the Inclusions list route is not available on this study. Nothing is wrong: add the subject from the Subjects page, then include them from their eCRF tab. |
Why the subject ID is typed on some studies and generated on others
Someone chose a Subject ID pattern when the study was set up, and it is often not the person who later adds the subjects. That choice is what decides whether you type the ID or the platform builds it for you, and it is also what decides whether the Inclusions list route works.
If your study was set to | The subject ID is |
Center abbreviation + Incremental | Generated. Both routes work. |
Center code + Incremental | Generated. Both routes work. |
Incremental | Generated. Both routes work. |
Free Text | Typed by you. Use the Subjects page. |
Custom | Depends on the pattern. If it includes a free text placeholder, you type that part, and you need the Subjects page. |
💡 Tip: you do not need access to the settings to work out which one applies to you. If the window asks you to type an ID, it is Free Text or a Custom pattern with free text in it. If the ID appears on its own, it is one of the generated patterns. Either way, adding from the Subjects page always works.
The pattern is set under Settings > Options > Subject ID pattern, and the person who manages your study can preview any format before saving it. See Set a Subject ID Pattern.