Anticoagulation clinics protocols

ASHP Foundation provides an example of an anticoagulation clinic protocol. 

The specification of the samples (serum, plasma or urine), sampling method, volume and number of samples should be stated in the clinical trial protocol and the information provided to the volunteer. In the case of plasma samples the anticoagulant to be used should be specified in the protocol. 

Sometimes a clinical site may deviate from the study protocol-defined sample-collection procedures. For example, instead of collecting blood into heparinized tubes, the sample may be collected into a tube containing another anticoagulant, such as citrate or EDTA. Under these conditions, it is necessary to cross-validate each of the plasma/serum matrices QC samples in the deviant matrix must be prepared and processed along with the deviant samples to ensure that the method is validated in the new matrix. 

---