As we say in Dutch: een goed begin is het halve werk (a good start will pay off). This part of your project can take a lot of time, and it will pay off! The following guidelines will help you not to forget about important preparation items:
- Pilot study
- Data management plan
- Data entry methods
- Recruiting and training data collectors
- Recruiting and training data entry clerks
- Dealing with study participants
- Please note, that there are stricter requirements (trial master file and eCRF e.g.) for Clinical Trials with pharmaceuticals and Medical devices that fall under GCP regulation/ WMO-high/medium risk.