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How to Abstract Interventional Trial Design Details

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.

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

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3. In the drop-down lists and text fields, select or enter 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) Info 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?	Include Page Expanded Access field description - Include v4.4 Expanded Access field description - Include v4.4
   Anchor primarypurposeinterventional primarypurposeinterventional Primary Purpose*	1. Select the primary reason for conducting the trial. The following list provides valid values. Include Page Primary Purpose Values - Include v4.4 Primary Purpose Values - Include v4.4 2. Optionally, if the primary purpose is Other, type a detailed description of the trial’s purpose in the text field provided. Info The text field is displayed only after you have selected Other.
   Secondary Purpose	1. Select one of the following reasons for conducting the trial. Include Page Secondary Purpose Values - Include v4.4 Secondary Purpose Values - Include v4.4 2. If the secondary purpose is Other, enter a detailed description of the trial’s purpose in the text field provided.
   Trial Phase* Anchor 5753 5753	1. Select the current phase of the trial. The following list provides valid values. Include Page Trial Phase Values - Include v4.4 Trial Phase Values - Include v4.4 2. If the trial phase is N/A, indicate whether the trial is a pilot by selecting Yes or No from the Pilot Trial? drop-down list. Info The Pilot Trial? drop-down list is displayed only after you have selected N/A.
   Intervention Model*	Select one of the following main study designs. Include Page Intervention Model Values - Include v4.4 Intervention Model Values - Include v4.4
   Number of Arms* Anchor numberofarms numberofarms	Type the number of treatment groups in the trial. Note title Important 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 one of the following masking types. Include Page Masking Values - Include v4.4 Masking Values - Include v4.4
   Masking Role(s)*	If you selected a blinded masking type, select one or more of the following roles as appropriate for the masking type. Subject Investigator Caregiver Outcomes Assessor
   Allocation*	Select the means by which participants are assigned to an intervention group. Include Page Allocation Values - Include v4.4 Allocation Values - Include v4.4
   Study Classification	Select the type of primary outcome or endpoint that the trial is designed to evaluate. Include Page Study Classification Values - Include v4.4 Study Classification Values - Include v4.4
   Target Enrollment*	If the Enrollment Type is Anticipated, enter the target number of subjects in the study. Tip 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 Anchor 6433 6433	If the Enrollment Type is Actual, but the final enrollment has not been recorded, you can enter the final number of subjects accrued. Info 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.

4. Click Save.

How to Abstract Non-Interventional Trial Design

1. Search for the trial of interest. In the search results, click the NCI Trial Identifier link for that trial.

2. On the Scientific Data menu, under Non-interventional Trial Design, click Design Details. The Non-Interventional Trial Design - Design Details page appears.

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3. In the drop-down lists and text fields, select or enter the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.

   Field	Description/Instruction
   Study Type*	Select Non-Interventional. (Selected by default)
   Expanded Access?	Include Page Expanded Access field description - Include v4.4 Expanded Access field description - Include v4.4
   Non-Interventional Trial Type*	Select one of the following trial types: Include Page Observational Study Definition - Include v4.4 Observational Study Definition - Include v4.4 Include Page Ancillary-Correlative Definition - Include v4.4 Ancillary-Correlative Definition - Include v4.4
   Primary Purpose* Anchor primarypurposenoninterventional primarypurposenoninterventional	1. Select the primary reason for conducting the trial. The following list provides valid values. Include Page Primary Purpose Values - Include v4.4 Primary Purpose Values - Include v4.4 2. If none of the values is appropriate, select Other, and then enter the same Non-Interventional Study Type you selected earlier, either Observational or Ancillary -Correlative , in the text field. Info The text field is displayed only after you have selected Other.
   Trial Phase* Anchor 5753 5753	1. Select the current phase of the trial. The following list provides valid values. Include Page Trial Phase Values - Include v4.4 Trial Phase Values - Include v4.4 2. If the trial phase is N/A, indicate whether the trial is a pilot by selecting Yes or No from the Pilot Trial? drop-down list. Info The Pilot Trial? drop-down list is displayed only after you have selected N/A.
   Study Model*	1. Select the primary strategy for subject identification and follow-up. The following list provides valid values. Include Page Non-Interventional Study Model - Include v4.4 Non-Interventional Study Model - Include v4.4 2. If the study model is Other, type a detailed description of the trial’s study model in the text field provided. Info The text field is displayed only after you have selected Other.
   Time Perspective*	1. Select the temporal relationship of observation period to time of subject enrollment. The following list provides valid values. Include Page Non-Interventional Time Perspective - Include v4.4 Non-Interventional Time Perspective - Include v4.4 2. If the time perspective is Other, type a detailed description of the trial’s time perspective in the text field provided. Info The text field is displayed only after you have selected Other.
   Biospecimen Retention	Select the DNA retention indicator from one of the following: None Retained -No samples retained Samples With DNA -Samples retained, with potential for extraction of DNA from at least one of the types of samples retained (e.g., frozen tissue, whole blood) Samples Without DNA -Samples retained, with no potential for DNA extraction from any retained samples (e.g., fixed tissue, plasma)
   Biospecimen Description	Specify all types of biospecimens to be retained (e.g., whole blood, serum, white cells, urine, tissue).
   Number of Groups/Cohorts* Anchor numberofarms numberofarms	Enter the number of treatment groups/cohorts in the trial. Enter 1 for a single-group study. Many observational studies have one group/cohort; case control studies typically have two.
   Target Enrollment*	Type the target number of subjects in the study. Tip 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.

4. Click Save.