Form and data FAQs

Can I view related data in two forms at the same time?

Yes. If your study assumes a relationship between two different sets of observations (for example, adverse events and concomitant medications), the study might have forms that you can link.

When you link two forms, you can see both sets of data at the same time. Both forms are the type that have a New button for entering repeating data. For more information, see Associate related data.

Can I skip an item or form?

Yes. However, for a form to be complete, you must enter all required items (marked with an asterisk).

If you don't have all of the data when you fill in a form, skip the missing items. When you submit the form, the missing items have a yellow background, and you can enter the data later.
If your study protocol allows it, you might need to skip an item or a form permanently if:
- The item or form does not apply to the subject.
- The data is not available.
- The procedure to collect the data was not done, and the data was not collected.

To mark an item or form as skipped, create a comment on the item or form. For more information, see Mark a form or item as incomplete.

Can I include clinical data in a comment?

Many sponsors prefer that you don't. Check with your sponsor representative before including clinical data in a comment.

Why can't I edit a form, visit, or case report book?

It might be locked or frozen.

Freezing prevents data entry and updates, including comment entry, but does not prevent query, source verification, and signing activities.
Locking prevents all activities except signing.

If the status icon for the form, visit, or case report book includes a frozen () or locked () icon, contact a sponsor representative and ask for the object to be unfrozen or unlocked so that you can edit it.

What are signatures used for?

Signatures on a form or case report book confirm that required work is done. The significance of a signature is specific to a study, and the signature's meaning appears on an affidavit page that a signer signs.

What if the data changes after I sign?

If a user updates a signed form, you have to sign the form and case report book, if applicable, again. The Sign or Sign Book link for the form reappears in the Signature column of the Signatures page.

I accidentally entered the wrong user name or password when I signed a form. What should I do?

When signing, you have the same number of tries to enter a correct user name and password as you do when you log in.

If you fail to enter the correct user name and password after the configured number of tries, you are logged out and your account is deactivated.

To reinstate your account, contact your system administrator.