Every clinical study is led by a principal investigator, but real decision maker is the Sponsor. According to the definition the Good Clinical Practices’ guidelines, the Sponsor is responsible for the initiation, management and/or financing of a clinical trial
Below we describe 5 main aspects Sponsors should be aware of when running a clinical study:
- 1. Subjects
The Sponsor should follow the guidelines established by the GCP to protect the safety and well-being of human subjects when they participate in a clinical trial.
During the study, the Sponsor should notify any findings that could affect the safety of the subjects.
- 2. Quality
The Sponsor is responsible for implementing and maintaining a quality assurance and quality control system to ensure the trial is conducted according to protocol, the Good Clinical Practice (GCP) , and the regulatory requirements.
The possibility of being audited is real and everyone involved in a trial should work with quality requirements in mind.
- 3. Data handling
The first step of data handling is to design the protocol and the CRF and decide how the analysis will be done to obtain the clinical data and trial reports.
During the study, all data should be reviewed, including safety data:
- All data changes should be documented
- A security system should be in place to assure the quality and privacy of the collector data
- Regular backup of all the data should be in place
- A system to safeguard the blinding should be set in place
All essential documents of the trial will be retained for at least 2 years after formal discontinuation, or after the last approval of a marketing application in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) region, or more if required by the regulatory requirements or by the Sponsor.
The clinical trial monitor during the study is the person in charge of verifying the data is accurate, complete and verifiable from source documents.
All reports prepared during and after the study will be turned into the regulatory agencies.
- 4. Investigational product
Before human exposure, the Sponsor should support safety and efficacy data from non-clinical studies.
The investigational product and also the placebo, if required, should be manufactured in Good Manufacturing Practices (GMPs) and labelled to protect the blinding with a coding system in case of emergency.
After receiving the approval of the Institutional Review Board /IRB, the Sponsor is in charge of supplying the investigational product to the investigator including instructions in written form. The Sponsor should also maintain records and assure storage in perfect conditions.
- 5. Agreements
All agreements should be in writing with the investigator or the institution / sites, as well as any other party involved within the clinical trial. If any duty is transferred and assumed by the Clinical Research Organization (CRO), it should be specified in writing.
Also, all financial aspects between the Sponsor, the investigator and the institution should be included in writing.
A clinical trial is a complex process with many actors involved and is the responsibility of the Sponsor to define all the duties and functions within the trial and keep track of everything.
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