Handling and storage of data and documents
Samples will be ordered in a computerized clinical system and tracked through a Clinical Trial Data Management system. Samples will not be sent outside NIH without appropriate approvals and/or agreements, if required. All specimens obtained in the protocol are used as defined in the protocol. Any specimens that are remaining at the completion of the protocol will be stored in the conditions described below. The study will remain open so long as sample or data analysis continues. Samples from consenting participants will be stored until they are no longer of scientific value or if a participant withdraws consent for their continued use, at which time they will be destroyed. If the participant withdraws consent his/her data will be excluded from future distributions, but data that have already been distributed for approved research use will not be able to be retrieved. The PI will record any loss or unanticipated destruction of samples as a deviation.It is expected that up to 1 year may be required to enroll up to 5 evaluable participants. To allow for a small number of in-evaluable participants to be replaced, the accrual ceiling will be set at 7 participants.