Automation of the inherent safety analysis also makes it more thorough and detailed, minimizes or eliminates human errors, facilitates documentation and makes the study results available online for detailed safety analysis and review in the later stages of process design.
We examined associations between whether studies had any authors from a low or middle income country (yes or no) and the following variables: year of publication, cancer site, funding type, multi- versus single-centre participation, use of placebo, type of treatment, treatment aim, type of randomized trial, ethics documentation, and whether the study mentioned informed consent.
Access to the study documentation system and the study database requires user authentication and is restricted to the responsible study staff.
All de-identified data, protocols and documentation from the study will be made openly accessible to the public and disseminated via a public-access website.
The procedures set out in this study protocol are designed to ensure that the sponsor and the investigator abide by the principles of the ICH Guideline for GCP (E6) and the Declaration of Helsinki concerning the conduct, evaluation and documentation of the study.
In addition to the study procedures and documentation of the study data, dementia-specific contents were included in the training curriculum.
Consequently, the study documentation and the questionnaires were adapted and in the pilot phase of the study a final standard-pretest (N = 5) was done to test responsiveness and feasibility.
Trainees were given a four-week period after their training session to undertake the TRM and submit completed TRSR documentation to the study leaders.
