Learn before Action
A glance at potential problems to be encountered in the implementation process
How is the payment ratio decided in the contract?
The ratio is decided according to the project contract amount and its difficulty factor.
Why is the quote so high?
The quote includes fees for CRO services, hospital, and the third party, and it varies greatly according to the difficulty of projects.
Why is the trial protocol repeatedly modified during the confirmation process?
After it is prepared, the draft needs to be submitted to frontline clinical researchers for review. There will be discussion on protocol design by researchers via protocol consultation or discussion meeting to learn about their practice experience. After the meeting, communications with researchers are needed to gradually revise and improve the protocol with the requirements from GCP, relevant disease guidance and ethics taken into consideration, in order to make it both comply with all relevant policies and regulations and clinically operable.
When will the protocol draft be provided?
It will be submitted within 15- 20 working days after Market Department gives the order that the project is confirmed and the research starts.
Why is the fee for the primary sponsor so high?
the primary sponsor plays a vital role in the entire clinical trial. As the main responsible unit for the trial, it needs to fully manage and supervise the whole process of the trial.
Why are subject observation fees high for some projects, but low for others?
The observation fees vary as affected by the factors including the clinical trial complexity, cycle of trial, subject risks, professionalism of research centers, and regional differences.
Why is the institute management fee high?How is it charged?
The clinical trial institute is responsible for quality control and supervision in the project, so a part of the observation fee charged serves as the fee for centralized management conducted by the institute, and the proportion is usually 30%.
When will the primary researcher be determined?How is the selection conducted?
Under general circumstances, the primary researcher will be determined around 30 working days after the cooperation agreement is signed with the sponsor.
Why is the trial cycle long and the process slow?
The length of the trial cycle depends on the difficulty of the indications in the project, the length of the clinical observation period, seasonality of specific diseases, competition from similar projects, drug clinical efficacy, and patient sources in the hospital, etc.
Why is CRC used?
After the "CFDA 722 Incident", almost all hospitals and institutions require that CRCs should be equipped in clinical trials. The aim is to ensure the clinical trial quality and promote the process to some extent.
What is the trial process?
The process generally includes: project establishment meeting - protocol discussion meeting - ethics conference - project initiation training session - screening and recruiting - medication and visits - data entry and cleaning - blind review meeting - statistical analysis report - summary meeting - cover seal of summary report.
When will the protocol abstract be provided?
It can be submitted within 5-7 working days after the project establishment.