Accelsiors Record Management ensures that years of valuable effort are preserved. Our system is based on state-of-the-art archive facilities, specialized electronic record management software, strict procedures and dedicated highly qualified staff.
It is a requirement of regulatory authorities that certain documentation generated during the course of clinical research is retained by the Sponsor and the Investigator for specified periods of time after work has been completed. These documents have to be stored in conditions that allow data to be located in a timely manner, to be available for reference or inspection and to be used as needed for patient filing or/and regulatory purposes. The management of these documents therefore requires a process for their collection, indexing, archiving and retrieval.
Regulatory requirements for collection and retention of clinical trial documentation divide responsibilities between Sponsor and Investigator/Institution. Regulatory authorities may require access to documentation kept both by the Investigator/Institution or by the Sponsor for inspection purposes, in order to assess compliance of the Investigator, Sponsor and Field Monitor with the standards of GCP and with all other applicable regulatory requirements.
The term Records Management refers to the administrative function in Accelsiors concerned with the creation, organization, maintenance, use, retrieval, and disposition of records. By assuring that valuable records are preserved and made available while needless records are disposed-off in a timely fashion, records management promotes economy and efficiency within Accelsiors.
The centerpiece of a records management system within Accelsiors is the records retention schedule (or Record Disposition Schedule). The schedule describes the contents and purpose(s) of each type of record or record series, and presents the retention requirements for each record series. For every Accelsiors’ Record Series a Record Disposition Schedule is going to be established with provision of Disposition Instructions and allocation of Disposition Authority.
We maintain electronic reflection of Trial Master File using electronic record management system specifically tailored for Accelsiors purposes- Knowledge Tree. Knowledge Tree allows Accelsiors as well as authorized sponsor representatives real-time secure link access to their study documents. Documents will be scanned and structured according to pre-established structure of individual record series. Every record will be provided with set of METADATA and a study specific Record Management Plan will describe in details quality and quantity of Metadata fields required for every record.
Both clinical staff and Accelsiors employees skilled in documentation management are engaged in this comprehensive task.
