10.2 MONITORING At regular intervals during the study, representatives of the monitoring team arranged by EctoPharma Ltd will visit the study centre. The average monitoring frequency will be dependent on the rate of recruitment at each site. At each monitoring visit, the Investigator and the monitor will review study progress, compliance with the study protocol, CRFs and any emergent problems. The monitor will ensure compliance with the protocol, adherence to regulatory and ICH obligations, accurate reporting of adverse events, maintenance of trial records including study product accountability records and correct administration of trial procedures including supply and storage of trial materials. Consent forms will be reviewed to verify that they are being correctly signed and dated by the subject/guardian and the Investigator. The monitor will require direct access to all records other than the CRF needed to verify the entries on the CRF. It is the responsibility of the Investigator to ensure that the subject is aware that such access will be required and that this information is available to the monitor. The Investigator (or his/her designated deputy) agrees to co-operate with the monitor and other clinical research personnel to ensure that any problems detected in the course of these monitoring visits are quickly resolved. 10.3 PROTOCOL AMENDMENTS Any changes to the protocol will be documented as a protocol revision (before the start of the trial) or amendment (after the start of the trial). Revisions/amendments will be submitted for approval to the IEC from which ethical approval for the trial was obtained and to the regulatory authority. Documented approvals of the revision/amendment by the IEC and the regulatory authority must have been received by EctoPharma before being implemented. The exceptions to this are when the change is necessary to eliminate an immediate hazard(s) to the trial subjects or for administrative (non-substantial) amendments involving only logistical or administrative aspects of the trial (e.g. change of responsible personnel, change of telephone numbers). Administrative amendments do not need ethical
10.2 MONITORING At regular intervals during the study, representatives of the monitoring team arranged by EctoPharma Ltd will visit the study centre. The average monitoring frequency will be dependent on the rate of recruitment at each site. At each monitoring visit, the Investigator and the monitor will review study progress, compliance with the study protocol, CRFs and any emergent problems. The monitor will ensure compliance with the protocol, adherence to regulatory and ICH obligations, accurate reporting of adverse events, maintenance of trial records including study product accountability records and correct administration of trial procedures including supply and storage of trial materials. Consent forms will be reviewed to verify that they are being correctly signed and dated by the subject/guardian and the Investigator. The monitor will require direct access to all records other than the CRF needed to verify the entries on the CRF. It is the responsibility of the Investigator to ensure that the subject is aware that such access will be required and that this information is available to the monitor. The Investigator (or his/her designated deputy) agrees to co-operate with the monitor and other clinical research personnel to ensure that any problems detected in the course of these monitoring visits are quickly resolved. 10.3 PROTOCOL AMENDMENTS Any changes to the protocol will be documented as a protocol revision (before the start of the trial) or amendment (after the start of the trial). Revisions/amendments will be submitted for approval to the IEC from which ethical approval for the trial was obtained and to the regulatory authority. Documented approvals of the revision/amendment by the IEC and the regulatory authority must have been received by EctoPharma before being implemented. The exceptions to this are when the change is necessary to eliminate an immediate hazard(s) to the trial subjects or for administrative (non-substantial) amendments involving only logistical or administrative aspects of the trial (e.g. change of responsible personnel, change of telephone numbers). Administrative amendments do not need ethical