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Research Article Open Access
Objectives: Before executing a clinical trial there is a lot of administrative work to do. The initiator of the study has to ask for and create several essential documents such as contracts, study protocol and case report form to name but a few. The aim of this research was to identify the current main challenges and time consumption during this planning phase of an investigator initiated trial (IIT).
Methods: A survey was conducted among monitors, principal investigators/study nurses, sponsors, study managers, federal authorities and ethics committees to capture the durations and delays of creating the Essential Documents of a clinical trial and their transmissions to the corresponding addressee. The questionnaire dealt with general information about the participant, the essential documents according to good clinical practice (GCP), the study protocol and the process of approving the documents and consequently the clinical trial.
Results: The responses showed that 95% of the participants maintain that the creation of the Essential Documents and waiting for the contributors is the most time consuming process in the planning of a clinical trial. Thereby the study protocol, contracts and (electronic) case report forms ((e) CRF) take 48% of the time in order to create all 20 Essential Documents. For that matter the survey showed that waiting for responses from reviewers and second examiners takes more than five weeks in average. Furthermore it showed that the coordination between the involved parties (45%) is a major time factor during the creation of the study protocol.
Conclusions: The survey identifies the enormous potential for optimizing the creation and transfer of the essential documents during the planning phase of a clinical trial. Furthermore it shows that the planning and coordination between editors, contributors and reviewers are a significant bottleneck before starting a clinical trial and should be supported better.
Investigator, Survey, Protocol, Good clinical practice, Ethics, Investigator, Survey, Protocol, Good clinical practice, Ethics