What's in the Folders on the REPRIEVE (A5332) PSWP?
What's in the "Study Monitoring" folder?
A Data and Safety Monitoring Board (DSMB) was established by the NHLBI to monitor data and oversee patient safety in the REPRIEVE trial. You will find Summary Reports of DSMB meetings in this folder.
Sites are required to forward these reports to their IRBs/ECs and file them in the regulatory files. The monitors will look for documentation of the submission to the IRB during the regulatory file review.
Currently, these memos and reports are in the Study Monitoring folder:
- Summary Report of the June 2015 DSMB Meeting and a memo from the REPRIEVE team about the findings of that review.
- Summary Report of the September 2014 DSMB Meeting. This was the first meeting of the REPRIEVE (A5332) DSMB when the Board reviewed the Study Protocol, Monitoring Plan, Consent Form, and DSMB Charter.
What's in the "Lab Resources" folder?
This folder contains the Lab Processing Charts (LPCs) for the current version of the protocol and other useful resource material related to lab tests and the LDMS. Remember that there are different LPCs for ACTG sites and sites not in the ACTG (non-ACTG sites). Because ACTG sites are collecting additional lab specimens, we felt it would be easier and less confusing to create separate LPCs.
Here is a list of what is currently in the Lab Resources folder:
- The current LPC (in Word and in PDF file formats)
- LPC (in Word and in PDF file formats)
- Lab Details from WebLDMS Training
- Lab Processing Worksheet
- Shipping Schedule – very important! Check your site’s schedule of when to ship samples to the specimen repository (BRI).
- Specimen Worksheets - this folder contains worksheets for each visit.
- Step-by-Step Guide for LDMS Entries using the REPRIEVE Processing Worksheets – this is a guide that sites can use if their processing lab does NOT have LDMS access.
- WebLDMS Reference Guides
- Specimen Management
- FDA 1572 Template