TTOG3210 - Case review and registration: Review case entry, control and closure procedures: All cases under review to be recorded as Review cases

TTOG3110 outlines the purpose and objectives of Review cases within the SI case control system.

It is essential where an Investigator is considering whether or not to initiate an investigation that all risks should be recorded on caseflow. This is a mandatory instruction.

SCIG01540 explains the importance of updating caseflow. Even if the chances of a case becoming a full investigation are slim it must still, if it has been considered for registration, be entered on caseflow as a review risk. The review procedures should be followed.

It should be noted that many SI investigation cases have been reviewed more than once before registration takes place. Maintaining the correct Review case entries on caseflow will help the right decision to be made, by allowing all known information to be accessed during each review process.

In cases where Local Compliance is seeking verbal advice there is no need to create a Review. The Investigator should, however, make a note for the Local Compliance Liaison file.