Electronic signatures are an important aspect of eCRF monitoring to ensure traceability and security of collected data.

EasyMedStat offers advanced capabilities for both investigators and monitors.

The eCRF offers 2 levels of signatures: "sign" and "verify". They are usually used as follows:

• Sign: for investigators
• Verify: for monitors

However, you are free to define a specific procedure for your study and use these features differently.

Audit trail

When an electronic signature is completed by an user, the following information are recorded:

• The user who signed
• The date and time of the signature
• In some cases, an associated piece of information like the source for a verification, or a reason for unsigning

A signature can be removed by an user but the associated audit trail will not be deleted.

Signing a patient form, a category or a variable

It is possible to sign different parts of an eCRF:

• The patient form: this is done at the end of the study when all data has been entered for the patient
• One or several categories or subcategories: at the end of a visit, or after filling a subsection of a visit
• One or several variables

All these signatures are independent of each other. You can sign a variable without signing the containing category, and you can sign a subcategory without signing the parent category or the patient form.

Therefore, if you sign a patient form, the signature is affixed to the whole patient form. The audit trail will store the patient form signature, but a specific audit trail will not be created for each variable of the form.

Electronic signatures do not prevent data entry

After signing, the content of the patient form can still be edited.

If you want to prevent further data entry or edition, you can use the lock function.

Related articles

• Disable electronic signatures for a study