Continuing Review: Tissue Collection Reporting
Version Date: March 7, 2017
Guidance on answering the tissue collection questions in the continuing review application
2.1 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 draw study in which subjects can enroll in the study more than once, providing blood samples multiple times).
2.1.1 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.
2.2 Provide the total sample size approved by the IRB
This number can usually be found in your IRB-approved ARROW application, typically within the Research Design and Procedures; Subject Population; or Collection and/or use of Biological Specimens section. If your study has a stand-alone protocol, the sample size should be reflected there as well.
If your study involves obtaining more than one sample or specimen per subject (e.g., 3 samples per subject and 20 subjects enrolled), please provide the total number of samples (e.g., 60 samples total).
If the IRB did not approve a specific number of specimens to be collected, enter zero in this field.
2.3 Provide the total number of samples, specimens, or images obtained to date
If you have only identified
potential samples or specimens, please enter zero and provide an explanation as to why collection has not begun (e.g. funding changes, lack of resources).
2.4 Provide the total number of additional samples, specimens, or images yet to be obtained
Indicate the number of samples or specimens that are yet to be collected or received for study purposes.
If the IRB did not approve a specific number of specimens to be collected, enter zero in this field and use the text box in question 2.5.1 to clarify that the IRB has not approved a specific number of specimens to be collected.
2.4.1 If no additional samples, specimens or images are yet to be collected, is the study open only for data analysis and all other study procedures are complete?
Check “yes” if the study is in data analysis only.
2.5 Provide the difference between (the number of specimens that have been obtained to date + the number of specimens yet to be obtained) and (the number of specimens approved by the IRB)
If the difference does not equal "0", please clarify the difference (e.g., fewer samples were identified for eligibility that originally estimated; the IRB did not approve a specific number of specimens to be collected).
If you wish to collect more samples than originally approved by the IRB, you will need to submit a change of protocol to increase the sample size before you can collect additional samples.