Adding Participating Sites to Abbreviated Trials - Include v4.4

(To add your organization as a participating site to a Complete trial, contact the lead organization.)

Once added, you can update your site's record at any time.

Trial information that you can update after adding your site includes the following:

• Organization's local trial identifier
• Site principal investigator
• Organization family's program codes
• Site recruitment status and dates

How to Add Your Organization as a Participating Site

1. Select the trial that your site is participating in. The Available Actions column in the search results table displays actions currently available for the trial.

2. In the Available Actions column, click the Select Action button and click Add My Site. The Add Participating Site page appears. The Participating Site list contains all organizations in the Organization Family associated with your CTRP account.

3. From the Participating Site list, select the organization that you want to add to this trial. Click Next. Another Add Participating Site page appears.

4. In the Local Trial Identifier field, enter the identifier used at the participating site.
5. Next to the Site Principal Investigator field, click Look Up to search for and select the site principal investigator.

6. (Optional) Specify a contact for the trial at this participating site. You can do so in one of the following ways:

   • Next to the Site Primary Contact field, click Look Up to search for and select the site primary contact. 

   • Next to the Generic Contact field, click Look Up Generic Contact to search for and select a CTRP person record.
7. (Optional) Consider whether the default contact information for the selected person record is appropriate for the trial at this participating site. The system accepts either the contact’s primary telephone number or the contact’s primary email address. You can provide both if available. Enter the phone number in the format 123-456-7890. You can provide an extension if available.
8. (Optional) In the Program Code field, select one or more program codes for the trial. The Program code field lists all program codes available for the organization family.

9. Add site recruitment status information:

   1. Select or enter the appropriate information in the text fields and drop-down lists. The following table describes the fields. An asterisk (*) indicates a required field.

      Field	Description/Instructions
      Site Recruitment Status Date*	Enter the date on which the current trial status became effective. To ensure that you record valid status dates, review the information provided in CTRP System Rules for Study Status and Dates.
      Site Recruitment Status*	Select the current stage or state of the trial or study.  The system validates all status transitions when you save a status record. If you add or update a status transition that does not conform to the rules provided in Status Transition Rules, the system displays errors and/or warnings. Warnings indicate that fixing the status record is optional; you do not have to resolve the transitions. However, Errors indicate that you must resolve the transitions by correcting trial status records.

   2. Click Add Status. The Site Recruitment Status History section appears, displaying the site recruitment information you entered. 

   3. Repeat the process of entering a status date, entering a status, and clicking Add Status until you have entered all statuses for the site.
10. If the system displays Errors or Warnings indicating that the status you added is invalid, do one of the following.  

11. 1. To edit the status, in the Actions column, click the Edit icon. Then, in the Edit Trial Status dialog box, make changes as indicated in the Error and/or Warning message.

    2. To delete the status, in the Actions column, click the Delete icon. Enter a comment indicating the reason why you deleted the record. Then add the correct status information.

12. Click Save. Your information is added to the trial details.