Services for clinical studies
Shorter consultations are provided at no charge while more in-depth project support and training are provided on a fee-for-services basis. Feel free to contact us for any inquiry.
Services offered at no charge
Shorter consultations on single occasions, by e-mail, telephone, or personal meetings. Examples of issues addressed:
- Application procedures – Advice as to the necessary approval bodies for your project and the required documentation. Guidance to provide 'help for self-help' until you complete the application.
- Document review – Review of the content of documents required for any clinical research project.
- Monitoring/Quality assurance – Help for self-help in compliance with regulatory requirements for quality assurance for clinical studies, as with providing document templates and support for conducting quality audits.
- Laws, regulations, and guidelines for clinical research and studies – Guidance in how to respond to specific issues raised by applicable regulatory frameworks for a specific clinical research project.
- Registration of study protocol in public database – Administrative support for registration of study protocols on Clinicaltrials.gov.
Project-specific support and active collaboration of resources linked to the Unit throughout all or part of your clinical research project. This includes longer and more detailed consultations.
Examples of services:
- Project Management/Logistics – Project management during planning, execution, and completion of your research project on assignment of the researcher or research team.
- Application procedures to appropriate governmental authorities – Preparation of documents for a complete application to appropriate authorities. For example, to the Swedish Medical Products Agency, Regional Ethics Committee, Regional Biobank etc.
- Quality assurance/Monitoring – Preparing monitoring plan and other essential documents, and performing monitoring of a clinical trial.
- Case Report Forms (CRF) – Prepare CRF (data collection forms) in paper or electronic formats based on a study protocol.
- Two-day GCP (Good Clinical Practice) - course providing content that fully complies with the requirements set for GCP training. Held twice yearly.
- Shorter GCP courses as an introduction to GCP, or as an update of previous GCP training based on the needs of specific research teams. On demand.
- Specialist training course awarding 7.5 college credits for nurses who specifically work with clinical research or studies. In collaboration with department of Health Sciences, faculty of Medicine at Lund University.
- Three-day course in quality assurance/monitoring for nurses.
In addition, we can gladly offer customized courses or seminars that address the specific needs of your department or research group.