RBM Knowledge Transfer

 

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.

 

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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 Instruction-PM-3010: Certification for the Use of Electronic Signatures
  • Work Instructions-PM-3007: Generating and Using Certified Electronic Copies
  • Template: Letter to certify to FDA use of electronic signatures
  • Template: Attestation for users of electronic signatures
  • Link to Training for clinical researchers on 21 CFR Part 11: Regulation for electronic signatures, certifying documents, and audit trails. Note the link to all videos can be found under the Webinar tab.

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.

  • Work Instruction-PM-3005: Using the eISF and eTMF with ShareFile
  • Work Instruction-PM-3009: Developing and Maintaining and Essential Document Checklist for use with ShareFile eTMF/eISF
  • Work Instruction-PM-3008: Sending a document for Electronic Signature (ShareFile)
  • Specifications for eTMF_eISF_Common Reference Documents including Role Access and User Testing in ShareFile

Quality Management Policy

Quality is the basis of all risk based monitoring and remote trial management.

  • POL 2001

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

  • Technology Vendor Requirement Template: eSource/ePRO/eConsent
  • Technology Vendor Requirements: eTMF/eISF
  • Template: Vendor Audit Template