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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