Documents you need before starting a clinical trial
There are several documents that need to be in place before any clinical trial can begin under Good Clinical Practice rules. The focus is very much on being able to demonstrate that all parties fully understand what they are getting into and are protected by adequate procedures, resources and, in many cases, insurance.
In a nutshell, all trials require the following before they can proceed:
The Investigator brochure
You must show that the investigator has been given relevant and current scientific information about the product being tested.
The Trial Protocol
This must include any amendments and should be signed to show the agreement of both the Sponsor and Investigator. It should also contain any sample case report form (CRF).
Copies of information given to and received from trial subjects
This demonstrates that subjects were provided with appropriate written information to support their decision to give informed consent plus the consent forms themselves. It is also important to include information of the recruitment practices used, such as a copy of any advertisement for participation in the trial.
Summary of financial and insurance arrangements
It is important to document the financial agreement between the Investigator and the Sponsor to show that everything is above board. Insurance may also be required to demonstrate that compensation would be available should the participants suffer any trial-related injuries.
Signed agreement between all parties
It is essential for the smooth running of any trial that every party understands what their role and responsibilities are. There must be signed agreements not only between the Investigator and Sponsor but also any CRO involved and, in some cases, the regulatory authorities.
Ethics committee approval
The final, but vitally important thing to obtain is approval of the relevant ethics committee/institutional review board (IRB). This written and dated approval shows that the above documents have been checked and approved and that the trial itself meets the rules for a safe and ethical trial. The version numbers of each document must be included to ensure that changes were not made after the approval was obtained.
All of these should be kept in both the files of the Sponsor and the Investigator and/or their institution. They should be seen not just as a necessary step to pass inspections but as vital elements of a safe, effective and scientifically-valid trial.
Whitehall Training is an online course provider, with courses on good clinical practice, pharmacovigilance, GMP and GDP.