How to Abstract Interventional Trial Design Details

1. Search for the trial of interest. For instructions, refer to Searching for Trials in PA.

2. In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.

3. On the Trial Identification page, check out the trial. For instructions, refer to Checking In and Checking Out Trials. (This checkout step is optional for Super Abstractors.)

4. On the Scientific Data menu, under Interventional Trial Design, click Design Details. The Interventional Trial Design Details page appears.

   Screenshot TBD.

   
   

5. On Interventional Trial Design Details page, in the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

   Trial Details	Instruction
   Study Type*	Select Interventional. (Selected by default) If you select Non-Interventional, the page will display the fields associated with non-interventional trials and you may lose any data you may have entered already.
   Expanded Access?
   Primary Purpose*	1. Select the primary reason for conducting the trial. For valid values, refer to Primary Purpose Value Definitions.  2. Optionally, if the primary purpose is Other, type a detailed description of the trial’s purpose in the text field provided. The text field is displayed only after you have selected Other.
   Secondary Purpose	1. Select one of the following reasons for conducting the trial. 2. If the secondary purpose is Other, enter a detailed description of the trial’s purpose in the text field provided.
   Pragmatic Trial	1. Trial Details - Pragmatic Trial 2. Instruction - Select Yes or No from the drop-down list to indicate whether the trial you are registering is a pragmatic trial.
   Trial Phase*	Select the current phase of the trial. For valid values, refer to Trial Phase Value Definitions.
   Is this a Pilot?	Select Yes or No from the drop-down list to indicate whether the trial you are registering is a pilot trial.
   Interventional Study Model*	Select one of the following main study designs.
   Model Description	Provide any available details about the Interventional Study Model.
   Number of Arms*	Type the number of treatment groups in the trial. The number of arms you enter in this field must coincide with the number of trial arms you recorded or will record on the Arms page (see Abstracting Arms). Do not leave this field blank or enter "0" (zero).
   Masking*	Select all of the roles that are masked, or select No Masking: Participant: The participant (or subject) is unaware of the intervention assignment. Investigator: The investigator is unaware of the intervention assignment. Care Provider: The care provider (or caregiver) is unaware of the intervention assignment. Outcomes Assessor: The outcomes assessor is unaware of the intervention assignment. No Masking: All people involved in the study know the identity of the intervention assignment.
   Masking Description	Provide any available details about the masked parties.
   Allocation*	Select the means by which participants are assigned to an intervention group.
   Target Enrollment*	If the Enrollment Type is Anticipated, enter the target number of subjects in the study. Do not give a range. Add the number of subjects in each arm or phase together to get the total enrollment if needed. Use the informed consent document to help you to identify the target enrollment if the protocol is unclear.
   Final Enrollment for ClinicalTrials.gov	If the Enrollment Type is Actual, but the final enrollment has not been recorded or the value was corrected for the Results Reporting, you can enter the final number of subjects accrued. The system records a count of 0 if you do not enter a Final Enrollment accrual count, and the number of subjects accrued to date is 0.
   Accruals	The system enters the number of accruals recorded to date in the CTRP automatically. You can not change this number.

6. Click Save.