gms | German Medical Science

Background: Research projects, especially clinical trials, need the support of students who can make important experiences in the practical implementation of a trial protocol by their administrative support.

Both student research assistants (SRA, without a bachelor degree) and research assistants (RA, with a bachelor degree) collaborate in the trial „Be-Up“ [1]. SRA support the trial team in the administrative job of supplying the obstetric teams of 17 participating hospitals in 7 federal states with material. The hospitals take part in the trial „Be-Up“ since April 2018 and recruit and randomise a total of 3,800 nulliparae and multiparae. RA monitor the trial teams’ data collection and documentation in the case report forms (CRF) and check their correctness and validity.

Aim/Research Question: What do students (SRA, RA) learn about the practical implementation of a randomised controlled trial in midwifery science? How do the students (SRA, RA) see their role? Which aspects give special pleasure to them – and which pose a challenge? In which way do these experiences enrich the students‘ acquisition of key skills in the implementation of research projects?

Methods: This workshop is conducted based on the method of facilitated conferencing [2] starting with a moderated interview of experienced peers (students), followed by questions from the audience that are answered and discussed by the students.

By means of this approach, the facilitator’s questions, the students‘ authentic experiences, and the questions of colleagues in the audience will provide opportunities for discussing particularly interesting aspects. In this way the participants can learn from the students’ practical examples.

Results: In the workshop the students will provide insights in new learning experiences that are partly outside of their subject area and which relate to the organisation and implementation of administrative and monitoring tasks, as well as the challenges of flexible working hours within a frame of payed weekly hours as an employee.

The SRA will speak about the issue how they realise the preparation of the CRF for the collection of objective data, the forwarding of questionnaires for the repeated collection of subjective data and the organisation of the follow-up in coordination between themselves and the team.

The RA will speak about their function and the key role of monitoring, sources of error in the documentation and mode of correction based on the guideline for GCP (good clinical practice), the communication with the hospital midwives and doctors and the writing of their report.

Relevance: Because research on the one hand is an important part of the development of midwifery science and midwives working in and out-of-hospital on the other hand will be increasingly involved in research, the practical participation of students in the implementation of research projects and clinical trials is of special importance.

Recommendations/Conclusion: During their study programme, students should be encouraged to acquire additional key skills by means of collaboration in a research project. The tasks of a SRA/ RA awakens the students‘ interest in research, prepares them for the role of a ’study midwife‘ and qualifies them for a future collaboration in the implementation of a clinical trial.

Ethics and conflicts of interest: A vote on ethics was obtained. The research was supported by external funding. There are no conflicts of interest.