If the lab reports infers a certain lab value, in this instance say, "Ex" - meaning Exclusion and it clearly relates to an exclusion criteria, then, the subject has to be excluded from the study.

For eg: If a protocol demands the lab parameter Hb (Hemoglobin) to be between 10-14 g/dl and a subject's report says 9.8 g/dl and that investigator comments saying "not significant", in such a situation, the subject cannot be considered to be eligible for the study ; as it has a bearing on the exclusion criteria. Monitor has to reiterate the fact that the subject cannot be included in the trial.

Alternately, if the same is seen in further visits and investigator comments as "not significant", then the monitor can accept the same, as appropriate, because the investigator's clinical judgement will play a role in further treatment administration. If the same is judged to be 'Clinically significant', subsequently, the following actions will be ensured.

ICH-GCP 4.3.2: During and following a subject's participation in a trial, the investigator/institution should ensure that adequate medical care is provided to a subject for any adverse events, including clinically significant laboratory values, related to the trial.

4.11.2 Adverse events and/or laboratory abnormalities identified in the protocol as critical to safety evaluations should be reported to the sponsor according to the reporting requirements and within the time periods specified by the sponsor in the protocol.

Regards
Sushma

Dear All,

If the one of parameter is EX and it is not corelating with other related parameters as all the other relating parameters is all within the limits then can't this be a error in the testing lab? so can't  the PI then mark as NCS and continue with the subject.... 

Regards
Seema

I assumed 'EX' in the above discussion means Exclusionary. Assuming the same to your point seema,

No, the investigator cannot continue this patient until and unless the point you have made that the error is  in the lab results is proved and new lab results are available corresponding to inclusionary values.

Otherwise, the whole purpose of the protocol and scientific study we talk about is defeated.

Dear pnreddy,
                 Sorry but i didnt get how can anyone challenge the lab result.As this result are given by central lab of the sponsor which have good accrediation & evrything goes according to sop and GLP . I would like to ask that can any investigator challenge the result of central lab of sponsor and can he use other lab for further investigation i.e. (spc for that criteria only not for complete study)
                Whose decision will be final??? sponsor or investigator???

Tushaar..

Dear Tushar,

Even in a central reference lab(CRL) things can go wrong & to add the lab need not be of the sponsor only this activity can be outsourced to any accredited CRL.  So i think PI can ask for a retest of the sample for that particular parameter....& the result will be the base for the final decision

Regards
Seema

Thanks sushma, seema and pnreddy now i am cleared about this..

Tushaar..