Overview of study-specific documentation

Online study documentation is an optional feature of the InForm application. Depending on the way your study is set up, you might have access to one or more of the following types of study documentation:

• Protocol—A copy of the sponsor’s study protocol, formatted for online viewing, that describes in detail how the study is to be conducted.
• CRF Help—A set of instructions and other details about specific CRF data items or about an entire CRF.

  CRF Help is an optional feature that allows you to display study documentation that describes a particular item or form. If your study is set up with this feature, you can navigate directly from the item or form to the study documentation.

  CRF Help can also include information about the edit checks on CRF items.

  You can also link directly to CRF Help on a CRF or CRF item, if your study is set up to provide those links. If these links are set up, the CRF name and the item descriptions in a CRF are underlined.

  If certain forms or items are particularly confusing, or generate many queries, ask your study administrator to create additional form help for the forms or items.

• Visit calculator (Subject schedule)—A copy of the Visit Calculator page that optionally appears at the end of the enrollment process.

  The Visit Calculator page computes suggested visit dates based on the date of the enrollment visit. You can edit the start date to determine suggested visit dates that conform to the visit timing that is specified in the study protocol.

• Sample study case report book—A complete set of read-only blank CRFs that you can use to familiarize yourself with the layout of the forms and visits.