PNS, but not SEP, was associated with a significant reduction in DU time (22 days, p < 0.007). The gap analysis revealed a 22-day gap between contract negotiation and institutional review board (IRB) verification and intervals of 33 days (contracts) and 48 days (BRI verification) during which the process steps were performed alone, indicating potential utility for parallel processing. These basic data support a study plan of the causes of the lengthening of the duration of studies by studying the causes of variations and outliers. How many copies of the agreement are needed? The standard is 3 copies (one for the principal investigator, one for the Institute and one for the sponsor); However, there may be exceptions. Clinical trial agreements in which one of the parties is La Fe Hospital or Manises Hospital are subject to the conditions described below. These last two documents do not have to be presented before the start of contract negotiations. How is the financing plan for the agreement calculated? Of the costs set per patient, 25% are intended to cover indirect expenses and the rest goes to the chief researcher. Processes that have nothing to do with contract negotiations are the subject of persistent concerns about clinical research management and shared responsibility among all stakeholders, including external partners in organizing organizations. In this regard, we point to several potential objectives such as a lack of coordination of processing between IRB control, budget negotiations and the conclusion of a contract, as well as a large variance between university sites in their process flows. Success is important for all parties to clinical research, including participants, clinicians, institutions, sponsors and the public.

The common goal of more efficient and cost-effective quality clinical research has led the CTSA consortium to give high priority to the exchange of efficient process improvements in the field of clinical research management. In this prospective contract management study, we gathered descriptive data on process steps related to contract negotiation and execution and approval of clinical trial minutes from 29 academic institutions associated with the CTSA. We cover here only contracts negotiated and executed during the study period from October 1, 2009 to December 31, 2010, for a total of 457 days. . . .