MANA RBM’s commitment to sharing its expertise and work product, as described and limited entirely herein, includes the many advancements we have pioneered and developed over the past 8 years in the areas of developing, testing, and evaluating methods for risk-based quality management and remote trial management. We hope you will adopt and use these effective tools, methods, documents, and training to better monitor trials remotely and increase the safety of all study subjects.
MANA RBM shares the documents and information as follows:
SOPs, Work Instructions, Templates for implementing electronic signatures and converting documents to certified electronic copies
Work Instructions, Specifications, and Templates for implementing an electronic Investigator File using ShareFile and RightSignature by Citrix. ShareFile offers a more basic and manual method than larger systems. RightSignature is integrated into ShareFile. This allows you to send documents for electronic signature from within the eTMF or eISF, a huge time savings. RightSignature can be used independently or with ShareFile. ShareFile’s reporting is not as robust as larger systems and there is not a way to manage metadata. Nevertheless, ShareFile’s modest cost places it within the budget of any company and any study.
All site documents (regulatory and subject source) can be accessible and reviewed remotely as certified electronic copies. PHI can be protected using the role-based access. Additional SOPs will be released to manage final archiving and role-based access.
Quality Management Policy
Quality is the basis of all risk based monitoring and remote trial management.
Debarment Check Work Instruction. We collect the data for debarment and delegation of authority in our Site Tracker Analyzing Risk (STARTM) database, which is our customizable “CTMS on steroids” database. MANA RBM will release the details of how to use its proprietary STAR database in the near future.
Vendor Selection and Review. A key question asked by Government regulators