1. Center for Human Drug Research
On-campus extended course Clinical Development
Center for Human Drug Research

2. Paul Janssen Futurelab Leiden
On-campus extended course Clinical Development
Course participant
Mentor(s)
Armida Fabius
Pierre Peeters & Rob Zuiker
&
Kirsty van Nierop
Marcel Kenter & Koos Burggraaf
&
Marjolein Kroonen
Gabriël Jacobs & Adam Cohen
&
Martine Lamfers
Matthijs Moerland
Mathilde Kouwenhoven
Geert Jan Groeneveld
Meta Roestenberg
Robert Rissmann
Sander van Asbeck
Adam Cohen
Marieke Pierik
Koos Burggraaf & Saco de Visser
&
Paul Janssen Futurelab Leiden

3. Program Friday September 15, 2017
Time Subject Discussion leader/ contribution Where
08:30 – 08:40 Opening & introduction Adam Cohen /Marcel Kenter + Mentors Auditorium
08:40 – 09:05 Presentation by participant #1 incl. 10 min discussion
09:05 – 09:30 Presentation by participant #2 incl. 10 min discussion
09:30 – 09:55 Presentation by participant #3 incl. 10 min discussion
09:55 – 10:20 Presentation by participant #4 incl. 10 min discussion
10:20 – 10:40 Coffee/tea break Cafeteria
11:40 – 11:05 Presentation by participant #5 incl. 10 min discussion Adam Cohen /Mentors Auditorium
11:05 – 11:30 Presentation by participant #6 incl. 10 min discussion
11:30 – 11:55 Presentation by participant #7 incl. 10 min discussion
11:55 – 12:20 Presentation by participant #8 incl. 10 min discussion
12:20 – 13:00 Wrap-up and matching mentors & participants
13:00 – 14:00 Lunch Cafeteria
14:00 – 15:00 Presentation alumnus Ruud Verstegen to be announced Auditorium
15:00 – 15:15 Short tour in CHDR to be announced CHDR
15:15 – 17:30 Individual work on clinical protocol Meeting room C & D
Send draft clinical protocol to your mentor(s) before Sunday 19:00 CET

4. CCMO template research protocol & structured risk analysis
The research protocol must contain an introductory section explaining why the research is to be carried out. The scientific and social relevance of the project should be indicated with references to:
Peer reviewed papers published in scientific journals (an overview of the references can be given in chapter 14).
The results of any pre-clinical studies with potential clinical significance and of any clinical trials or studies relevant to the proposed research should be summarized.
Convincing arguments should be given that there is not sufficient knowledge available to explain the problem or for the need to test what is known.
It should be clearly stated which new information this study may add to what we already know.
This section should also explain why the research needs to be conducted with the selected population. This is particularly important where minors or incapacitated adults are to be used as subjects.

5. Paul Janssen Futurelab Leiden
CCMO template research protocol & structured risk analysis
the Lancet 2006, 368:
Paul Janssen Futurelab Leiden

6. Paul Janssen Futurelab Leiden
On-campus extended course Clinical Development
Wifi code
Netwerk: FutureLab
Wachtwoord: welkombijfuturelab
Netwerk: CHDR Guests
Wachtwoord: Welkom01
Paul Janssen Futurelab Leiden