Common use of Study Documentation Clause in Contracts

Study Documentation. The Investigator will retain a copy of all study documents in accordance with local or FDA regulations, whichever are the more stringent. For information, the regulations of the FDA state that the Investigator will retain study documents: (a) for a minimum of two years following the date a marketing application (New Drug Application or NDA) is actually approved for the drug for the proposed clinical indication; or (b) if the FDA has been notified that no marketing application is to be filed by BioMedicines, or if the marketing application has been filed but is not approved by the FDA, then for a minimum of two years following the release date of the final report; or (c) if neither a) nor b) applies, then for a minimum of fifteen (15) years after the completion or discontinuation of the study. (d) The Investigator must obtain BioMedicines’s written permission before disposing of any records. If the Investigator relocates, retires or for any reason withdraws from the study, then the study records may be transferred to an acceptable person or institution with the written approval of BioMedicines. The Investigator agrees to maintain a complete and current record of all documentation associated with the study. All of the documents should be kept together. Each should be available for ready review. These study documents will include the: (e) protocol, including the case report forms (f) protocol approval page with all required signatures (g) protocol amendments and approval pages (h) signed FDA Form 1572 or similar local form as appropriate (i) Investigator’s current curriculum vitae (j) documentation of IRB or Ethics Committee approvals for the protocol, amendments, informed consent, and advertisements used by the investigator to recruit patients (k) current clinical laboratory certification (l) range of normal laboratory values