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Overview: Using trial documentation
Online trial documentation is an optional feature of the InForm application. Depending on the way your trial is set up, you can have access to one or more of the following types of trial documentation:
- Protocol—A copy of the sponsor’s trial protocol, formatted for online viewing.
- CRF help—A set of instructions and other details about specific CRF data items or about an entire CRF. CRF help can also include:
- Information about the edit checks on CRF items.
- Frequently Asked Questions (FAQs), which provide answers to questions about CRF items. FAQs are responses to questions and issues that come up when users enter data in CRFs. Based on the experiences of users who are entering data, a FAQ can clarify instructions, provide additional details, or point users to resources that might be useful. FAQs are associated with specific data items on CRFs. Users with rights to maintain FAQs can add or update them in response to questions that come up during the course of a trial.
- Visit calculator—A copy of the Visit Calculator page that 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 specified in the trial protocol.
- Sample trial case book—A complete set of read-only blank CRFs that you can use to familiarize yourself with the layout of the forms and visits.
As well as giving access to trial documentation through the document window, the InForm application enables you to link directly to CRF help on a CRF or CRF item, if your trial 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. As you pass the mouse cursor over a link, the cursor changes to a pointing-hand icon.
To display the CRF help for a CRF or CRF item:
- Click the underlined CRF name or item text.
