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Search for the trial of interest. For instructions, refer to Searching for Trials in PA.
In the search results, click the NCI Trial Identifier link for that trial. The Trial Identification page appears.
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.)
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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In the various fields, specify the appropriate information. The following table describes the fields. An asterisk (*) indicates a required field.
The following list providesField Description/Instruction Study Type* Select Non-Interventional. (Selected by default)
Expanded Access? Include Page Trial Design Expanded Access field - Include 20170406 Trial Design Expanded Access field - Include 20170406 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.
.For valid values
Include Page Primary Purpose Value Definitions - Include 20170406
- Include 20170406, refer to Primary Purpose Value Definitions
.
The following list provides2. If none of the values is appropriate, select Other, and then enter the same Non-Interventional Study Type you selected earlier, either
Observational
orAncillary -Correlative
, in the text field.Info The text field is displayed only after you have selected Other.
Trial Phase*
Select the current phase of the trial.
.For valid values
Include Page Trial Phase Values - Include 20170406 Trial Phase Values - Include 20170406, 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. 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.
- Click Save.