Services for clinical studies

The Unit for Clinical Study Support within Clinical Studies Sweden - Forum South offers advice, project support, and training related to planning and execution of clinical research studies for researchers and research groups.

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.

Fee-based services 

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.

Training

  • 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.

Course offerings for research (only on Swedish website)

In addition, we can gladly offer customized courses or seminars that address the specific needs of your department or research group.

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