Project Scope Develop a Data Reviewer’s Guide Template (referenced in the Technical Conformance Guide) and associated documents to allow up front communications regarding the sponsors interpretation of the Bio-research Monitoring Technical Conformance Guide. Initially, the scope will include the development of the template and then expand to cover the full suite of documents. The current cSDRG and ADRG templates will be considered to avoid unnecessary duplication of content. Therefore, revision of these templates are not in scope |
| Project Leads | |
| Julie Maynard | |
| Wendy Dobson (PHUSE Project Manager) |
| Project Members | Company |
| Dmitry Golubovsky | Teva Pharm |
| Jean Mulinde | FDA |
| Lin Yuan | Astellas |
| Michael Johnson | FDA |
| Nigel Montgomery | Roche |
| Phyllis Smetana | UCB |
| Sopan Kaith | Roche |
| Steven Clark | Astellas |
| Todd Rider | BMS |