There are many meeting summaries for clinical trials, including data review meetings and trial summary meetings. Here we try our best to introduce the whole process of clinical trials in an all-round way, some of which are inconsistent with company SOP management, please ignore.
- The emergence of clinical trials
Thanks to the sponsor’s (Party A’s) demand for product listing or re-evaluation, clinical trials were approved by the sponsor.
- Clinical trial budget
Generally, the budget of human, financial and material resources will be put on the agenda at the beginning of the project. A large part of the success or failure of a clinical trial depends on an organization or a collection of organizations with sufficient human, financial and material resources.
- Procurement of clinical trials:
The procurement process fully reflects the relationship between demand and supply. Generally, Party A can entrust all or part of the operations in clinical trials to a third party. The third party includes one or more of the central laboratory, CRO, SMO, data management, statistical analysis, logistics, warehousing, and auditing.
- The budding of the plan (first draft)
The first draft of the plan is drawn up by the sponsor or CRO, and the quality of the first draft varies. But it is an important first step. In this process, project managers, medicine, statistics, and central laboratories play a very important role.
- Center screening
Center screening also determines whether the experiment can be carried out smoothly. The center screening visits usually include several methods such as telephone, email, and in-person visits to the site.
- Discussion and finalization of the plan
Discussion and revision with clinical and statistical experts will bring the plan closer to the operational level.
- Institutional project
The clinical trial institution is the department responsible for the management of clinical trials at the Site. The first step in communication with the Site is also an important step.
- Ethics meeting
Important documents such as the plan, informed consent, inspection report and qualifications of all parties are reviewed at the ethics meeting of the ethics committee, and approval opinions are given.
- Supply of test drugs/devices and materials
Prepare and supply drugs/devices and materials in accordance with the company’s SOP and program requirements.
- Contract signing
All parties involved in the clinical trial sign a two-party, three-party or multi-party contract to agree on their respective responsibilities and rights.
- Kick-off meeting
The department kick-off meeting is an important process such as training, authorization and handover. It is also an important milestone in clinical trials.
- Subject management
As subjects are screened, enrolled, followed up, and exited, clinical trials are gradually completed in the center. The data management of clinical trials is also being carried out at the same time and tends to be improved.
- Supervision
After the kick-off meeting, CRA began the supervision process. As the supervision deepened, the data and quality of the test tended to be perfect and meet the regulatory requirements.
- Data review meeting
After the clinical trial is over, all parties to the clinical trial will explain, categorize and process the important events and data in the clinical trial through a meeting. Prepare for the final data cleaning and lock library.
- Institutional quality control
The quality control personnel of the center and institution control the quality of clinical trials according to SOP to further improve the quality of trials.
- Third-party audit
Similarly, third-party auditors will audit clinical trials again, improving the quality of the trial in one step.
- Data cleaning and database lock-up
The data generated by clinical trials may deviate from the actual situation. CRA uses questioning and researchers answer questions until such deviation is gradually eliminated, and the database can be locked.
- First-level unblinding
After the data is locked, the first-level unblinding is performed, and the data is divided into A/B groups, but the experimental drugs or devices represented by the groups are not clear.
- Data statistical analysis
The statistical department completes the statistical analysis work in accordance with the statistical analysis plan and issues a statistical analysis report.
- Summary meeting
The summary will summarize the whole process of the clinical trial, summarize the advantages and disadvantages, and carry out the second-level unblinding of the blind bottom, clarify the corresponding drugs or devices in the A/B group, and further analyze the test results.
- Summary report
The main investigator or medical staff will describe and summarize the whole process of the clinical trial through a report, provide the corresponding data and give the conclusion of the clinical trial, and finally complete the report with the seal of all parties.
CD BioSciences was founded in 2004, located in New York. The company offers a full range of clinical trial consulting, design, conduction, management, reporting and analysis services to advance researchers’ clinical trial development needs. CD BioSciences has provided experienced professional support to local, national, and international clients. Its clinical trial services focus on the entire clinical trial lifecycle including bioanalytical lab testing, clinical pharmacology, first-in-human (FIH), proof of concept (POC), early phase trials, phase IIa trials, phase IIb-III trials, phase IIIb-IV trials, CDM analysis and reporting.