The development of a standard training toolkit for research studies that recruit pregnant women in labour

Recruitment of pregnant women in labour to clinical trials poses particular challenges. Interpretation of regulation lacks consistency or clarity and variation occurs as to the training required by clinicians to safely contribute to the conduct of intrapartum studies. The Royal College of Obstetricians and Gynaecologists Intrapartum Clinical Study Group initiated the development of a pragmatic, proportionate and standardised toolkit for training clinical staff that complies with both regulatory and clinician requirements and has been peer-reviewed. This approach may be useful to researchers in acute care settings that necessitate the integration of research, routine clinical practice and compliance with regulation.