As the Principal Investigator, you are responsible for ensuring that the data collected and entered onto the case report form or into the Electronic Data Capture system from your study site are authentic, accurate, complete, timely and legible.
All data captured for the purpose of the study must be supported by source documentation in your site’s records. A source document is defined as the first recording of an observation or result that is collected pertaining to the clinical trial.
The only exception where a supporting source document is not required is for data that is directly recorded by the subject into a remote data entry device such as an electronic diary.
Along with the subject source documentation, all study correspondence will need to be maintained. This includes correspondence from the sponsor, ethics committee and any other study information. Organizing and filing this information as it is received makes this task more manageable. At the end of the study, all of the study documents will need to be stored in a secure location.
For verification purposes it is critical to be able to determine who captured all data points for a study. Therefore, it is essential for the individuals capturing study data, sign and date ALL original source documents with either their full signature or initials.
Consistent with GCP, if it is necessary to correct or update data, the corrections must be made without compromising the original data entry. The original data in question must be crossed out with a single line and the correct information recorded on the document as appropriate. The correction must be signed and dated by the individual making the change. If a correction is not self-explanatory, a brief explanation should be included.
In the Electronic Data Capture environment an audit trail is automatically created for all changes made to the data. The system records who made the change, the date and time the change was made along with the reason for the change.
As mentioned at the beginning of this presentation, clinical trials must be conducted with the utmost regard for the safety and well being of the participants. Therefore any adverse experience that occurs to a study subject at your site that is considered to be “Serious” must be reported to the sponsor within 24 hours of learning of the event.
As a sponsor has a regulatory obligation to review and report serious, unexpected, drug-related Adverse Experiences to Regulatory Authorities. The site will report the event to the ethics committee. As the investigator, it is your responsibility to know who is responsible for reporting the event to the ethics committee overseeing the trial.
In addition, adverse experience causality assessment is vital to both establish and monitor the safety profile of new and approved drugs and vaccines; therefore, it is essential that all aspects of adverse experiences be reviewed by a qualified physician, particularly the potential relationship of the investigational product to the adverse experience. This assessment should be documented by the reviewing physician’s initials or signature together with the date this assessment was made.
In addition, all laboratory safety data be reviewed by a qualified physician for clinical significance and possible adverse experiences.
The data regarding the adverse event will need to be entered into the Case Report Form. The source document must support what is entered into the EDC system or onto the paper Case report form.
as outlined in ICH-GCP 4.3.1 A qualified physician (or dentist, when appropriate), who is an investigator or a sub -investigator for the trial, should be responsible for all trial-related medical (or dental) decisions. Part of this responsibility involves the timely and thorough review of (1) all laboratory safety data for adverse events and clinically significant trends and changes and (2) all adverse experiences for the assessment of causality and the medical management of the patient. While it is entirely appropriate for the study coordinator to ask the subject about any changes to medication or any new health-related issues which may be potential adverse experiences and document them in the chart, the primary investigator or sub-investigator who is a medically-qualified physician, is responsible for a thorough review of this information and for evaluating any and all parameters that require medical input, including, but not limited to drug relationship or causality
Even though the abnormal fasting blood glucose was fairly typical for this subject, the sub-investigator (who is a medically-qualified physician) needed to review the lab values to assess if the out of range value was significant from either a laboratory or clinical perspective. If she considered it was significant, it would be necessary to document a new adverse experience.
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