Long Term Archiving
Review, archiving, preservation and storage of documents related to clinical studies from the Experimental Center.
Issues
The main issues are highlighted:
Total or partial loss of documentation;
Replacement of personnel and consequent loss of contact with the Principal Investigator, who had been appointed by the Sponsor as the person in charge of the documentation relative to the Trial (retirement/ transfer of the Principal Investigator);
Scant attention paid to the problems involved in Archivig Clinal Trial documents.
The partnership
According to the GCP and ICH, "the documentation relating to a clinical trial must be retained at least two years after the last approval of a marketing application (AIC) and until there are no pending or contemplated marketing applications, or at least 2 years have elapsed since formal discontinuation of clinical development of the investigational products. These documents should be retained for a longer period however if required by the applicable regulatory requirements or by an agreement with the Sponsor".
Plurima and Hippocrates Research (LTA Partners) have sanctioned an agreement to make available to Corporate Clients, who promote drug discovery in Italy, their proven and specific skills, respectively: the former in Archiving (for leading Pharmaceutical Companies and Hospitals - custody of medical records, Rx ...), the latter in the conduction of clinical trials.
The Investigator must retain all trial documentation adopting safety measures in order to prevent accidental or premature destruction of these documents. Such measures should be more efficient than those adopted in the traditional archiving of documents. Unfortunately Hospitals and Universities often are not provided with adequate spaces and staff to guarantee
Hippocrates & Plurima (LTA Partners) provide their technical/scientific knowledge in monitoring clinical trials and the opportunity of maintaining |
