Common use of Essential Documents Clause in Contracts

Essential Documents. HPTN study sites must maintain a number of administrative and regulatory documents pertinent to each HPTN study in which they participate. These documents commonly are referred to as essential documents. Although sites are allowed some flexibility in their filing systems, all required documents should be stored in an organized manner and must be easily retrievable for review by the Clinical Site Monitor and other authorized individuals. Study sites are encouraged to begin organizing and filing required documentation upon receipt of the final study protocol and must maintain complete and accurate files from that time forward, in accordance with the record retention requirements stated in the study protocol. DAIDS requirements and additional guidance on management of essential documents is provided in the DAIDS SCORE Manual.