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Dr. JAYASHREE ICRI
DEFINITION AND PURPOSE
A Document that describes the objectives,design,methodology and statistical considerations and organisation of a trial Background and rationale for the trial Protocol amendments Content and format-SOP
to be comprehensive-users Information to study site staff Data collection and analysis. Clinical study report
of the sponsor company Regulatory affairs department Marketing department Medical literature Investigators brochure statistician
OBJECTIVES OF THE STUDY
and clearly defined As few as possible What can the results demonstrate
– Primary objective – Secondary objective
for inclusion and exclusion Inclusion
– Evidence to confirm the diagnosis
– Concomitant medication – Concomitant disease – Contra-indications
– Comparator or non comparator – Cross-over or parallel group
– Selection or allocation bias – Observer bias
– – – – – – – – Blinding method Quantities Period of use Compliance checking Packaging Labelling Storage and handling Escape medication and concomitant medication
– – – – – Schedule of events Investigations-central lab,relevant inv Adverse affects treatment-by ,to ,when Patient instructions Records and data collection-source documents,entry in to CRF , direct entry into CRF.
Assesment of efficacy and safety.
DESIGN COMPARATOR-PROS SAMPLE
SIZE STATISTICAL ANALYSIS
for the study should be ethical from subject’s point of view
– Ensure safety – Invasive investigations – Use of placebo
indemnity,audit and finance
of all participants Cultural variabilities
ordination – staff,monitor Responsibility – regulatory authorities,maintain data,ADR monitor Agreement – between company ,investigator,regulatory bodies. Funding ALL ACCORDING TO COMPANY SOP.
PROTOCOL REVIEW AND SIGN -OFF
for critical review Protocol writer-editor with a team Committee of individuals specified in the SOP
for dealing and tracking amendments are defined in SOP Review and sign off, ethics committee approval