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®
RuleBuilder - Access to Clinical Trials Data
RuleBuilder (Clinical Trials Data Access)
It is
permitted
prohibited
that a(n)
Principal Investigator
Investigator
Pharma Scientist
Researcher
Staff Researcher
Reviewer
Physician
Sponsor
Analyst
Statistician
Marketing Specialist
Company Manager
may
copy
forward
read
release
reproduce
scan-and-forward
modify
electronically sign
the following:
Medical Monitoring Plan
Trial Master File Plan
Trial Team Evidence of Training
Report of Prior Investigations
Marketed Product Material
Regulatory Approval Notification
Regulatory Progress Report
Coordinating Investigator Documentation
IP Unblinding Plan
Laboratory Results Documentation
Relevant Communications
, but only if (s)he belongs to the
Institutional Review Board
Merit Committee
Sponsor Team
Company Executive Team
Ethics Committee
Academic Subsite
Industrial Subsite
FDA
, this rule applying over the period
to
0%
For Use Under U.S. Patent No. 8,532,978
