Protocols

Protocols will only be accepted when these are included in a complete research study and comply with the applicable conditions such as raised by the WMO, the GCP regulation and the manual of the CCMO (also refer to www.ccmo.nl).

The MREC of the foundation BEBO differentiates in the complexity of submitted protocols. The classification is based upon the following principles:

Type Complexity
A
  • research study with a drug that is already registered in the Netherlands or in the EU
  • bio-equivalent research between two or more drugs of which one is already registered and does not apply to B- or C-research
B
  • research with a drug that is already registered elsewhere, but not in the Netherlands or the EU
  • research with different usage/application of a registered drug
  • follow-up research for phase I-, II- and III-studies
C
  • research with a new, not yet registered, potential drug (phase 0, I or II; first MREC submission)
  • general experimental research, including non drug materials (e.g. cosmetics, nutrition supplements, insecticides)
  • research with radioactive labelled compounds
D
  • a combination of multiple (2 or 3) C-studies in one protocol

The involvement of specific MREC members in a review procedure depends on the type of protocol:

Type MREC involvement
A/B one pre-advisor: physician or clinical pharmacologist or hospital pharmacist
C/D two pre-advisors: physician and clinical pharmacologist or hospital pharmacist
all other one pre-advisor; physician or registered nurse

Foundation Beoordeling Ethiek Biomedisch Onderzoek