Create the Study

You must create a new study for every new protocol before you can start planning each study.

You can create multiple plans or clinical scenarios for any given study.

1. On the Start screen or your custom-defined Home screen, select the option to view the list of existing plans.
2. From the Edit menu, select Studies.
3. On the Studies screen, click New.
4. On the Create Study screen, complete the General Information section.
   • For more information about a field, click the field label to display online help.
   • If the product entry has not already been created, from the Product/Compound drop-down list, select New to display the Create Product dialog box, and define a new product.
   • Your choice of Phase determines the assumptions you can specify in the Therapeutic Area & Indication section.
5. Complete the Therapeutic Area & Indication section.
   Indications are classified into therapeutic areas. ClearTrial uses the selected therapeutic area and indication to calculate monitoring time required, time for query resolution, and data entry, and to provide other default values for ClearTrial-defined assumptions. You can override these default values.

   Note:

   If you selected a Phase 1 study for either healthy volunteers or patients, you cannot choose a different therapeutic area.

   • By selecting Substitute the names below for therapeutic area and indication, you can specify an alias for the selected therapeutic area and indication for reporting purposes. The alias appears on the Studies screen, the plan header, and on all study-related reports.

     You should add a therapeutic area or indication alias if there are no therapeutic areas or indications included on the predefined list that match your particular study protocol when ClearTrial offers a similar indication.

   • To view a list of all therapeutic areas and their associated indications, from the Report menu, select Therapeutic Area/Indications Mapping.
   • When no therapeutic area or indication seems to fit, choose the most appropriate body system/therapeutic area for the study you are planning. If you cannot find the specific therapeutic area or indication you need:
     • Select a similar therapeutic area or indication from the available list and then use the Alias fields to substitute the name of the actual therapeutic area or indication.
     • Select Other from the list of therapeutic areas and choose either a similar indication or Other (Complex), Other (Routine), Other (Simple), or Other (Very Complex).
6. Add a description or note.
7. Click Save.