CCDM certification : Knowledge of Study protocol

To get certified as a CCDM you need good understanding of the clinical study protocol.

You should be able to identify the data elements that would be needed to fulfil the primary and secondary hypothesis.


The critical aspect is to map protocol with the aspects like CRF design, database design, data cleaning and evaluation of study results and safety data reporting.

You should be able to relate all objectives and information collected to have a "medical intent".

You should have good understanding of how protocol review is done and should be able train other CDMs on the protocol review process.

There are lot of sites which contain sample protocol : A good one is Roche Protocol Registry, Yale Disease list