Purpose: Establish a standard approach for ensuring the consistency, reliability and accuracy of rare disease care protocols
Scope: Pertains to all stakeholders involved in the development and evaluation of rare disease care protocols
Roles and Responsibilities
- Stakeholders – delineate responsibilities for RareCAP platform development, outline responsibilities of trusted care providers, patient advocates and family groups in the creation and input of care protocols to the platform. Interact with open comments promoting collaboration in rare disease care.
- RareCAP Medical Executive Team – review drafted care protocols for consistency, reliability and accuracy using the latest research available. Provide oversight on protocols to conform to platform design including formatting and editing for proper grammatical corrections. Collaborate with Medical stakeholders and Medical Advisory Board on questions or issues presented.
Development and Review of Protocols
- Protocol Creation – acceptable sources for information include using the latest research/literature and experiences to draft a protocol
- Information Sources – latest literature, experts in the specialty fields, and patient experiences
- Vetting Process – vetted professionals, foundation or family group with specialty interest/background with professional connections confirmed by RareCAP team/stakeholders.
- Protocol Draft review – drafted protocols submitted for publishing are initially reviewed by a physician. Content may then be reviewed by the RareCAP Medical Executive team, the RareCAP Medical Advisory Board or another designated expert in the specialty field before follow-up by the RareCAP curator for proper formatting, punctuation, precise wording and grammatical correctness.
- Verify resources and references
- Assess for compliance with any regulatory requirements or ethical standards
- Engage with patient/family advocacy groups/foundations and other experts within the specialty fields for feedback
- Ensure cultural and language appropriateness
- Publication to Platform – a final review by RareCAP curator prior to publication onto platform
Continuous Quality Control
- Feedback Loop – address comments/new information/findings based on feedback from the open comment forum, rarecap@vumc.org, or professional contacts.
- Comment Collaboration – Open comments forum, emails and professional communications regarding additional data, updates or addressing gaps in the care protocol will have priority consideration and go through the RareCAP Medical Executive team and/or additional experts within the specialty fields to review the protocol or removal of publication from platform until additions or corrections are made.
3.2 Periodic review – establish annual/biennial intervals for all published protocols
