Background and Importance The clinical trial (CT) initiation visit is the meeting designed to prepare the investigational site that will conduct the study. This procedure is performed with the site personnel who will assume study responsibilities. The staff is divided into an investigator team and a pharmacy team.
Aim and Objectives Quality assessment at the initiation visits of a clinical trial.
Material and Methods Observational, prospective, single-centre, prospective study to evaluate the quality at the start of a CE in a tertiary level hospital. The study period was from June to August 2022. A 16-item survey was carried out, which includes the aspects to be taken into account in the performance of a CE. The questions collected were: investigator service, phase of the trial, knowledge of the presentation and stability of the drug, mode of preparation, administration and destruction of the experimental product. When the trial monitor (CRA) knew the question, a score=1 was assigned if he/she did not know=0. The tools used were: Excel® for data collection, Fundanet® for EECC registration and Google Teams® for meetings. The maximum score obtained was 20 and a poor start was considered with scores below 13.
Results Thirty CT onsets were analysed during the study period. The main clinical services under investigation were: oncology > dermatology > haematology. The phases of the trials to be initiated were: III (14), II (10), I/IB (6) and IV (0). The mean quality score obtained was 16.62. There were 4 clinical trials with a score between 10-13 and 2 trials with a score of less than 10. This led to a second review of the CE by the sponsor, which meant a delay in the start of the investigation.
Conclusion and Relevance Although most of the clinical trials met the quality criteria for initiation, there is a non-significant proportion with poor results. In those clinical trials that do not meet the minimums, a delay in initiation is necessary for the resolution of doubts on the part of the sponsor.
References and/or Acknowledgements 1. Liu, M.B. and Davis, K.; Chapter 6: Monitoring. Lessons from a Horse Named Jim: a Clinical Trials Manual from the Duke Clinical Research Institute. Durham, NC: Duke Clinical Research Institute, 2001. Print.
Conflict of Interest No conflict of interest.
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