Important notice for Clinical Trials Sponsors to Information for Patients/Informed Consent Form

Information of SÚKL to Approval of Information for Patient / Informed Consent Forms  

State Institute for Drug Control (SÚKL) gives a notice to Sponsors (or Contract Research Organisations) submitting Applications for approval/notice of Clinical Trial, that during assessment of submitted documentation are approved only those Information for Patients / Informed Consent Forms (or versions to Healthy Volunteers, Parents/Legally designated representatives or guardians), which covers exclusively consent of subject with participation in Clinical Trial, eventually substudy, which is defined in Protocol (e.g. pharmacokinetic substudy, pharmacogenomic substudy etc.) concerning given Clinical Trial.

 

Other type of Informations will not be assessed or approved by SÚKL, e.g.:

  • Information for Patients / Informed Consent Form with usage of biological samples in future research (not concernig given Clinical Trial)
  • Information for Patients / Informed Consent Form with contacting pregnant partners of male patients
  • Information for Patients / Informed Consent Form for female partners of male participants in Clinical Trial
  • Information for pregnant partner and Consent Form with providing data about pregnancy
  • Information for Patients / Informed Consent Form with MRI imaging for Image Quality Assessment purposes
  • Information for Patients / Informed Consent Form with processing of personal data
  • Expression of a patient at discontinuation of study treatment
  • Information for Patients / Informed Consent Form with optional text message service
  • Information for Patients / Informed Consent Form with usage of photographies for educational purposes  

 

19. 3. 2014
Clinical Trials Department