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Table 2 Trial requirements and related problems.

From: Practices, patients and (im)perfect data - feasibility of a randomised controlled clinical drug trial in German general practices

Investigator duties (GCP) Provided by the study team Problems encountered Possible causes
Knowledge of ICH-GCP guidelines and regulatory requirements Information (ICH-GCP guidelines, German drug law etc.)
Training units within initiation/monitoring visits
Further training units on demand
Written material was not read Too much information provided in initiation visits
Providing resources (time, staff) Clarify responsibilities Workflow support
Additional support on request (by phone call, additional visits)
Lack of personal resources (during busy practice times) Under-estimation of additional trial workload
Recruitment of incident cases
Sufficient patient recruitment (screening, enrolment and documentation of all UTI patients) Involvement of practice nurse
Support by instructions, workflow
Low recruitment in some practices
Incomplete documentation for non-participants
Time constraints
Time gap between initiation visit and first inclusion
Number of refusals/patients with exclusion criteria under-estimated
Comply with regulatory requirements with respect to informed consent Extensive but GCP-conforming information sheets Patients felt overwhelmed with information
Patients did not read information completely before signing
Time-consuming procedure
Information sheet too extensive
Ensure complete and correct documentation (CRF, source data) Support by instructions, workflow
Data sheets for relevant source data
Incomplete CRFs
Problems with report of AEs
Extensive documentation not compatible with existing documentation habits
  1. Abbreviations: CRF = case report form, ISF = investigator site file, AE = adverse event