Continuing Review: Tissue Collection Guidance
Guidance on reporting tissue collection
Version Date: January 1, 2010
Can subjects provide tissue or samples more than once?
Check yes to this question if subjects will be invited to participate in the study more than once and provide samples each time they choose to participate (e.g., a blood collection study in which subjects can participate in just one blood draw session or can return multiple times for blood draw sessions).
If yes, provide the total number of subjects enrolled
Please provide the total number of subjects enrolled in the study, not the total number of samples, specimens or images collected.
Provide the total sample size approved by the IRB
If the UW’s role is limited to receiving samples, specimens or images to be analyzed for a larger, multicenter study (e.g. fundus photographs), please provide the total sample size of samples, specimens, or images approved by the IRB. If your study involves obtaining more than one sample, specimen, or image per subject (e.g., 3 samples per subject and 20 subjects enrolled), please provide the total number of samples (e.g., 60 samples total).
Indicate the number of samples, specimens and/or images that you have already collected or received for study purposes.
Please indicate whether you have obtained samples specifically for this research project
If you have only identified potential samples, specimens or images, please check “no” and provide an explanation as to why collection has not begun (e.g. funding changes, lack of resources).
Indicate the number of samples, specimens, and/or images that are yet to be collected or received for study purposes.
Please indicate if the collection of samples, specimens or images is complete, whether you have only data analysis
Check "yes" if the only study activity yet to complete is data analysis.
Please indicate how many samples, specimens, or images obtained
The number of samples, specimens, or images obtained should be added to the number of samples, specimens, or images yet to be obtained. Then the difference between this number and the number IRB-approved samples, specimens and images should be provided here.
If the total above does not equal "0", please clarify the difference (e.g., fewer samples were identified for eligibility that originally estimated.) If you wish to collect more samples that originally approved by the IRB, you will need to submit a change of protocol to increase the sample size.