Investigational Product Confirm that investigational product disposition 30 forms and accountability records are complete and present for all subjects receiving study drug Confirm final disposition of investigational product 31 was completed per MOP, site pharmacy protocol, supplier, and sponsor requirements Collected Laboratory Specimens (Samples) Confirm that all specimens have either been 32 analyzed or stored for future use Ensure that specimens collected for future use 33 have been adequately processed, and stored Confirm site process for identification and disposition of future use specimens connected to 34 subjects who withdraw consent or do not consent for their specimens to be saved Confirm destruction, per institutional policies, of 35 specimens not identified for future analysis Analysis, Manuscripts, and Submissions/Publications 36 Data analysis complete 37 Primary manuscript finalized Results submitted to Pubmed and ClinicalTrials.gov (as applicable) Intramural Studies: Confirm that notification has been made to the Office of Protocol Services 38 (OPS) for change in study status and update to ClinicalTrials.gov Extramural Studies: Confirm that the appropriate party has updated ClinicalTrials.gov with the update in study status Confirm final disposition of study supplies and any 39 equipment provided for the study: <insert items>
Investigational Product 30 Confirm that investigational product disposition forms and accountability records are complete and present for all subjects receiving study drug 31 Confirm final disposition of investigational product was completed per MOP, site pharmacy protocol, supplier, and sponsor requirements Collected Laboratory Specimens (Samples) 32 Confirm that all specimens have either been analyzed or stored for future use 33 Ensure that specimens collected for future use have been adequately processed, and stored 34 Confirm site process for identification and disposition of future use specimens connected to subjects who withdraw consent or do not consent for their specimens to be saved 35 Confirm destruction, per institutional policies, of specimens not identified for future analysis Analysis, Manuscripts, and Submissions/Publications 36 Data analysis complete 37 Primary manuscript finalized 38 Results submitted to Pubmed and ClinicalTrials.gov (as applicable) Intramural Studies: Confirm that notification has been made to the Office of Protocol Services (OPS) for change in study status and update to ClinicalTrials.gov Extramural Studies: Confirm that the appropriate party has updated ClinicalTrials.gov with the update in study status 39 Confirm final disposition of study supplies and any equipment provided for the study: <insert items>
Study_Close_Out_Checklist.docx