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 |