ROLES OF THE SPONSOR - UKM Medical Centre

G CP 

ROLE OF THE SPONSOR 

ADELINE KWOK 

HEAD OF CLINICAL OPERATIONS 

PFIZER(M) SDN BHD

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Objectives 

• Definition of Sponsor 

• Define the roles 

CRC GCP Workshop 2012 HUKM

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Who is the sponsor 

• An individual, company, institution, or 

organization which takes responsibility 

for 

- Initiation 

- Management and / or 

- Financing of the clinical trial 

ICH Guidelines for GCP 1.53 


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What are the roles 

Sponsor’s Role 

◦ Section 5.1 – 5.23 of ICH GCP 

guidelines 

Ethical & scientific quality standard 

for the design, conduct, recording & 

reporting of trials that involve 

human subjects. 


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1.Designing the trial 

• Utilize qualified individuals 

( biostatisticians, clinical pharmacologist, 

Study physicians) 

- design protocol 

- design Case Report Form 

- plan the analysis 

- analyze data & 

- prepare clinical trial reports. 

Scientific Integrity of trial, credibility of data 


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Trial Design 

• Ensure quality control & 

consistency – protocol & Case 

Report Form (CRF) 

What needs to be collected & 

how does the data need to be 

stored (format) 


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2. Delegate Medical 

Expertise 

• To advise on 

trial related 

medical 

questions or 

problems 


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Knowledge Check 

Study Design and Blinding 

• What does blinding in a clinical trial 

mean 

◦ Double Blind 

◦ Single Blind 

• What is the meaning of placebo 


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3. Manufacturing, Labelling, 

Coding 

• Manufactured/ packaged in 

accordance with GMP 

• Coded and labelled – blinding 

protected 

• Coding in blinded trials – mechanism 

for rapid ID in case of emergency, 

does not permit undetectable blind 

breaks 


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4. Supply & Handling of 

Study drugs 

• Request , import & custom 

clearance 

• Adequate storage 

• Provide site with information on 

handling e.g. route, dosage, 

frequency 

• Ensure Documentation of drug 

accountability, Inventory and 

Disposition of Unused supplies 


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Knowledge Check : 

Selection of Investigators 

• What criteria would be important for 

sponsors consideration 


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5. Select Investigator 

• Selecting investigators / sites 

- qualification 

- adequate resources - human, patient pool, 

facilities 

- time 

- conflicting studies 

- GCP trained & 

- feedback / previous records 


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6. Provide adequate 

information 

• Protocol 

• Investigator’s Brochure – safety & efficacy 

data of the investigational product from 

non- clinical studies and/or clinical trials. 

• Updates - significant new information 


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Knowledge check : 

Record Access 

• Question – who has access to patient 

records in clinical trials 

• What documents permit such access 

rights 


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7. Secure Agreements 

• Clinical Trial Agreement: - 

◦ conduct trial according to GCP 

◦ comply with data recording and reporting 

procedures 

◦ permit monitoring, auditing and inspection - 

to allow direct access to sites, data and 

reports 

◦ retain essential documents 


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Secure Agreements 

Indemnify Investigators 

• Legal & financial coverage to the 

investigator / institution against claims 

arising from the trial 

except 

for claims that arise from malpractice 

and/or negligence 


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Secure Agreements 

Financial Agreements 

• All payments / honorariums should be 

documented & agreed 

• Amount should justified & not extra ordinary 

• Payment in accordance with local regulatory 

requirements 


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8. Obtain Regulatory 

Approvals 

• Apply & obtain Clinical Trial Import License 

- Manufacturing method 

- Good Manufacturing Certificate 

- Stability data 

- Certificate of analysis 

- Sample labels, packaging diagram 

- Quantities 


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9. IRB/EC approval 

• Confirm/ Obtain from the investigator the 

IRB/EC approval 

• Ensure completeness of approval Letter : – 

- Protocol Title, version date 

- Statement of what was reviewed & approved 

e.g. Informed Consent – version date 

subject’s transport allowance 

advertisement 

- GCP statement QC 

- EC members list 


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10. Allocation of duties & 

functions documented 

• Prior to start of the trial obtain from the 

Principal investigator the following: - 

- Names of team members 

- Establish who does what 

- Their sample initials, signature 

- Duration of responsibilities 


Sponsor 

Responsibilities : 

11. Quality Control 

and Quality 

Assurance

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Knowledge Check 

• Is Monitoring QA or QC 

• What are the differences between 

Audit and Monitoring 

• What about the differences between 

Audit and Inspection 

• How often should monitoring be 

done 


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13. Ongoing safety 

evaluation 

• Promptly notify – findings that may affect : - 

- the safety of subjects 

- impact the conduct of the trial 

- alter the IRB/EC approval to continue the trial. 

• For all ADR are both serious & unexpected, 

expedite reporting to: - 

- all investigators 

- Independent Review Board 

- Regulatory authorities. 


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14. Trial Management/Data 

Handling/ Record Keeping/IDMC 

• Ensure maintenance of Essential 

Documents 

• Use of unambiguous Subject ID/ 

Confidentiality 


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Manage the Data 

Trial data (protocol required information) on 

each trial subject are captured : - 

• Paper Case Report Forms (CRFs) 

• Electronic Case Report Forms 

& Sent to the Data Manager 


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Data Management 

• Establish Data Handling Guidelines for 

standardization (QC) 

• Data entry guidelines eg. coding 

instruction/dictionaries (QC) 

• Data review. Edit checks (QC) 

specifications & query process 

• Programming specifications & guidelines 

• Statistical analysis plan (SAP) (QC) 


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• Quality Control 

should be applied 

to each stage of 

data handling to 

ensure that the 

data are reliable 

and have been 

processed 

correctly. 


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15. Records and Reports 

• What are Essential Documents 

in Clinical Trials 


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Records and Reports 

• Retain all Essential documents for at least 2 years 

AFTER the last approval of a marketing application 

in an ICH region and until there are no pending of 

contemplated marketing applications in an ICH 

region or at least 2 years have lapsed since the 

formal discontinuation of clinical development of 

the investigational product…… but may be longer. 

- Trial Master Files 

- Case Report Forms 

- any other trial related documents 

• Notify Investigator in writing 


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16.Premature Termination 

• Promptly inform the investigator , the 

IRB/EC and the Regulatory Authority of 

the reason(s) for termination. 


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17. Monitor compliance 

• Compliance with protocol, GCP, SOPs, 

Regulatory Requirements QC 

• Take prompt action to secure compliance 

QC 

• Terminate investigator if serious or 

persistent noncompliance – notify 

Regulatory Authority 


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18. Clinical Study Reports 

• Prepare and provide clinical study reports 

to the Regulatory Authority 

(whether the trial is completed or 

terminated) 


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19. Contract Research 

Organization 

• Role of Sponsor may be transferred 

• Contract signed 

• Assume the role of the sponsor & 

must comply with ICH GCP 

guidelines 


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Roles of the sponsor 

CRO 


Archive 

Audit 

Monitor 

Compliance 

Design Protocol 

SPONSOR 

Safety 

Medical Expertise 

Site selection 

Regulatory approval 

IRB/EC approval 

Secure agreements 

Drug Control 


Questions

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THANK YOU

ROLES OF THE SPONSOR - UKM Medical Centre

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