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Contents

Purpose

Record the details of research samples collected for each patient per protocol requirements.  

Specimen Status eCRF

Field Name

Description / Instructions

Format

Visit Date(m)

Enter the date the form was completed.

Note: If the information was obtained at multiple visits, please enter the date the form was completed.

DD-MMM-YYYY

Specimen IDEnter Specimen ID (Identifier)

30 Characters

Expected Collection Date of Specimen

Enter the planned or anticipated date when a sample (specimen) will be collected.

DD-MMM-YYYY

Expected Collection Time of Specimen

Enter the planned or anticipated time when a sample (specimen) will be collected in military format (24 hours). Seconds are optional and default to 00 if not entered.

Ex: 13:56:00 (for 1:56:00 PM)

 

In RDC Onsite studies, the lab time will be empty when the CRF is saved with time 00:00:00. Such time is being saved and simply not being displayed.

There is no way to indicate an 'unknown' lab time right now.


HH(24):MM:SS

Specimen Collected?

Select a Yes/ No/ Not Applicable answer to whether a sample/ specimen has been collected

Use pick list.

Collection Date

Enter the date when sample was collected.

DD-MMM-YYYY

Specimen Type

Select specimen type from the pick list: 

  • BLOOD PRODUCT

  • SLIDES

  • TUMOR BLOCK

Use pick list.

Submitted Reason

Select the explanation for the submission of a biospecimen from a patient.

Use pick list.

Other, Specify

Enter the explanation for submission of a specimen that is different from a list of options.

100 characters

Amount Obtained

Enter the number that describes the amount of specimen included in the sample.

5 digits and 2 decimals

Specimen Unit

Enter the unit of measurement applied to a biospecimen collection.

Use pick list.

Reason Specimen Not Collected

Select the reason a tissue specimen taken for research or analysis was not collected from the picklist:

  • INSUFFICIENT SPECIMEN

  • PATENT REFUSAL

  • SPECIMEN UNAVAILABLE

  • OTHER, SPECIFY

Use pick list.

Reason Specimen Not Collected; Other, specify

Use the free-text field to specify the reason a tissue specimen taken for research or analysis was not collected.

100 characters

Legend: (m) RDC mandatory

Validations

Code

Description

Resolutions

 

 

 

   
   

Derivations

Code

Field Name

Description

 

 

 

   
   
Last updated by Blackburn, Katie (NIH/NCI) [C] on Apr 18, 2017