Question16: Please list what is to be expected of a CRA in relation to study monitoring?

Answer:

Study Initiation:

Once a site has received IRB approval and the routing process has been completed, the sponsor will arrange the study initiation visit.  With exceptions, this is when most sites receive study drug and case report forms.  Most sponsors will not send drug to the site without at least provisional IRB approval.

Study initiation is an important time point in any study. This is the sponsor chance to get all the players at the site together for training on the study requirements and it serves as a signal that the project is now ready to get underway. It is important to include as many staff members as possible:

       Principal investigator

       Sub-investigator

       Coordinator

       Technologist responsible for laboratory testing

       Pharmacists

It is important that each individual clearly understands their role and responsibility in the project .Involving them in the project at the time of initiation by making them aware that they are part of the team and it is important for the study that they give their best.

The study initiation visit is another chance to show off the quality of the study site to the sponsor. These studies are best done with the Physicians who have a busy patient schedule so it can be a challenge to get the initiation on their schedule. Schedule the time with the Physicians for the lunch hour and provide some sandwiches, a treat appreciated by the Physicians as well as the sponsor staff.

Ensuring that the arrangements for storing and issuing the study drug and maintaining blindness (if appropriate) are in place. The storage space for the study drug must be secure and envoirmental appropriate. Ensure that a log of envoi mental conditions (example: temperature and humidity readings) is maintained. The pharmacy is also a key in the randomisation and blinding process and therefore in the smooth running of the trial.

Study Initiation Checklist

In-house

       Send study package(s) to field monitors (Protocol, Brochures, Consents, 1572, contracts/agreement letters, etc.)

       Submit appropriate documents to Regulatory Affairs and/or place in study file

       Submit initial grant payment request, if appropriate

       Send laboratory normal ranges to Biostatistician/Data Management

       Ship clinical supplies (notify field monitor (CRA) when drug is shipped)

Field

Conduct site initiation visits

Confirm receipt of clinical supplies with each site

Review protocol requirements

Review sponsor policy on CRF completion and correction

Confirm presence of all required documents

Ensure establishment of study files

Establish monitoring visit frequency and communicate to site