Presentation
Subunit responsible for the design of the study and the preparation of all essential documentation, which includes:
- Study protocol.
- Patient/subject information sheet.
- Informed consent.
- Paper data collection form (DCF).
It is also the subunit responsible for writing the study results reports (interim and final reports).
The methodologist is responsible for this task. However, this work is multidisciplinary, and coordinated and collaborative work among all parties involved in the study (researcher, company (if applicable), Institute biostatisticians) will be essential. The involvement of other Institute units (e.g., IT) will depend on the needs of the study.
The tasks corresponding to the methodological support subunit (according to the published rates):
- Clinical study design – Simple/complex protocol.
- Protocol adaptation.
- Preparation of the patient information and informed consent form (PI-IC).
- Adaptation of the patient information and informed consent form (PI-IC).
- Design of the paper data collection form (DCF).
- DCF review.
- Writing interim reports of the study. Study.
- Drafting the final study report.
- Reviewing the final study report.
