The Graduate Programme in Clinical Research

Faculty of Health Sciences
University of Southern Denmark

GCP and investigator-initiated Clinical Trials

Preliminary Programme

Monday,March 14th2016

09.30– / Welcome
Introduction to the course
Presentation of participants and the GCP-unit / Charlotte Calov
The GCP-unit,Odense University Hospital (OUH)
10.00– 10:30 / Introduction toGCP and Legislation
  • Principles and Definitions
  • Stem cells and medical devices
/ Tanja Bidstrup
The GCP-unit, OUH
10.30– 10.45 / Short break
10.45 – 12.00 / How to plan a Clinical Trial– part 1
  • Content and purpose of the protocol
  • CONSORT
  • Project management
  • Essential documents - TMF
Assignment 1: Agreements and procedures
Assignment 2: Delegationlog
Assignment 4: Screening list, ID-list and Randomisation list / Charlotte Calov, Tanja Bidstrup
The GCP-unit, OUH
12.00 – 12.30 / Lunch
12.30 – 14:15 / How to plan a Clinical Trial – part 2
  • Content and purpose of the protocol
  • CONSORT
  • Project management
  • Essential documents - TMF
Assignment 1: Agreements and procedures
Assignment 2: Delegationlog
Assignment 4: Screening list, ID-list and Randomisation list / Charlotte Calov, Tanja Bidstrup
The GCP-unit, OUH
14.15 – 14.30 / Short break
14.30 – 15.00 / Written agreements/contracts
  • When and how to draw up a written agreement/contract
  • Who can sign a contract
  • Data ownership and rights for publication
/ TBA
Juridisk kontor, University of Southern Denmark
15.00 – 15.30 / Collaboration with Hospital Pharmacy Funen / Anne Albinus, Lene Kristensen
Hospital Pharmacy Funen

Tuesday, March15th2016

08.30– 08.45 / Coffee and summary of day 1 / Tanja Bidstrup
The GCP-unit, OUH
08:45 – 09:45 / Quality Assurance and Quality Control
  • Risk assessment
  • Initiation
  • Monitoring
Assignment 3: Sourcedatalist / Charlotte Calov
The GCP-unit, OUH
09.45 – 10.00 / Short break
10.00– 12.00 / The Danish Health and Medicines Authority– application, protocol amendments,reporting and inspection / Maria Elgaard
The Danish Health and Medicines Authority
12.00– 12.30 / Lunch
12.30 – 14.30 / Requirements of TheResearch Ethics Committeesystem for Clinical Trials / TBA
The regional research ethics committee in the region of Southern Denmark
14.30– 14.45 / Short break
14.45 –15.45 / Adverse Events (AE) and Adverse Reactions (AR)
Exercisesand discussions / Henriette Kunoy Bendixen
The GCP-unit, OUH

Wednesday, March16th2016

08.30– 08.45 / Coffee and summary of day 2 / Tanja Bidstrup
The GCP-unit, OUH
08.45– 09.45 / Data protection during a Clinical Trial
  • Procedure of the notification of “public” research projects to the Danish Data Protection Agency
  • When can researchers seek information in patients’ medical records?
/ Dorthe Riskjær Larsen
Direktionssekretariatet, OUH
09.45– 10.00 / Short break
10.00– 10.45 / Case Report Form (CRF) and data management / Nina Drøjdahl Ryg
The GCP-unit, OUH
10.45– 11.30 / Electronic data management and databases / TBA, OPEN Odense
11:30 – 12.00 / SharePoint as elecronic Trial Master File (e-TMF) / Søren Ahlers-Jensen, Regional IT, Region Syddanmark
12.00 – 12.30 / Lunch
12.30 – 13:00 / Biobanks
Evt. Opgaver se CC / Janni Brødbæk, OPEN Odense Patient data Explorative Network
13.00 – 13.15 / The trial is running or is it? / Charlotte Calov, The GCP-unit OUH
13.15 – 13.30 / Short break
13.30 – 14.30 / Practical experiences from a Clinical Trial / Bjørn Stæhr Madsen
Phd-student, OUH
14.30– 15.00 / End of Trial
  • Archiving of Essential Documents
/ Tanja Bidstrup
The GCP-unit, OUH
15.00 – 15.15 / Course summarydiscussion
Evaluation