RESPONSIBILITIES OF SPONSER IN CLINICAL RESEARCH:
An individual, company or institute or organization which takes responsibility for the initiation management and financing of a clinical trial. He is the commercial manufacturer that has developed a product. Holds IND application and files NDA, BLA
Sponsor can be individual
Sponsors responsibilities are
1QUALITY ASSURANCE AND QUALITY CONTROLL
He is responsible for implementing QA and QC with written SOPs to ensure trials are conducted, datagenerated, documented and reported in compliance with protocol GCP and regulatories
Quality control should be applied to each stage of handling to ensure that all data are reliable and have been processed
2 RESEARCH ORGANISATION
Sponsor may transfer all this data to CRO, sponsor is responsible for quality of trial
Sponsor should designate qualifies medical personal for medical issues
Under quality individuals like biostatitian, pharmacologist, physicianetc.
5TRIAL MANAGEMNT, DATAHANDLING, RECORD KEEPING
Sponsor may consider establishing an independent data monitoring committee to assess the progress. They should be well known about feeding electronic data
6RESPONSIBLE FOR SELECTING INVESTIGATOR
Based on qualification experience investigator is selected.
An experienced investigators should be selected and make agreement
7 ALLOCATION OF RESPONSIBILITIES
Sponsor should be aware of the responsibilities which are allocates to his staff including investigator
8COMPENSATION TO SUBJECTS AND INVESTIGATOR
HE is responsible to give compensation in case of any adverse effects happened to subjects
All documents regarding financial data should be with sponsor. He must know the all financial aspects in a trial.
10 NOTIFICATION OR SUBMISSION TO REGULATORIES
If there is any notifications to regulatories like informed consent, written summary, etc. will be submitted by sponsor
11 CONFIRMATION OF REVIEW BY IRB OR IEC
Sponsor should be updated about regulatory reviews or if is rejected, reasons behind that
12 INFORMATION ON IP
Sponsor should have a knowledge about investigational product like indication, drug classification, route of administration etc.
13MANUFACTURING, PACKACAGING LABELING, CODING OF IP
He also should have a clear knowledge about IP, its expiry date its manufacture its warnings to be written on label, its code etc.
14SUPPLING AND HANDLING OF IP
Sponsor should be well known about the amount of raw materials given, what is remaining after product formation, who are the staff handling IP ETC
15 RECORD ACCESS
Any time when investigators or monitors or auditors asked for documents related to any it should be available to them as soon as possible.
Sponsor should be well aware about adverse drug reaction, its reporting to higherregulatories, monitoring, auditing etc. If it is done in multicenter, its study reports should be collected. If there is any premature suspension of ant trial sponsor should be well aware about that too.
From this it’s well understood that sponsor is one of the pillars of a clinical trial. Sponsor can also be investigator, then it’s called SPONSER INVESTIGATOR. For the successful completion of a clinical trial role of sponsor is very important.