Medical Monitors or Medical Directors are usually licensed physicians with expertise in clinical study conduct. They may be specialists with board certification related to the disease being studied or have experience with similar clinical trials. For some studies, a Veterinarian, Dentist, or Podiatrist, with expertise related to the study, may serve as the Medical Monitor.
Medical Monitors provide medical supervision of the clinical trial on behalf of the Sponsor. They do not actually conduct the study, that is the job of the Clinical Investigator. They may be employees of the Sponsor; may work for a Contract Research Organization (CRO), or may be freelance consultants.
Medical Monitors usually work with outside medical experts, Biostatisticians, Regulatory Affairs and Product Development staff to develop the study protocol. They review related literature to determine what type of efficacy assessments will be suitable. They work with the Biostatistician to determine sample size for the study based on the magnitude and variation of clinical effect expected. They usually collaborate with Data Management to design or review, the case report form templates.
The Medical Monitor works with the Sponsor’s pharmacologists and toxicologists and Regulatory Affairs to prepare the Investigator’s Brochure supplied to each Investigator.
Medical Monitors will interact with the the Clinical Investigators. The Investigators are responsible for selecting, treating and evaluating the subjects enrolled at their site. The Medical Monitor is responsible for overseeing the safety of all of the subjects at all of the sites; but the Medical Monitor does not directly participate in their care.
When designing the study and writing the protocol, the Monitor may consult with some of the Investigators who are experts in the disease being studied.
The Medical Monitor usually meets with all of the Investigators at the Investigator's Meeting to discuss the protocol and discuss how study assessments will be done.
The Medical Monitor monitor enrollment to ensure that only appropriate subjects are enrolled. Sometimes, an Investigator requests permission to enroll a subject who has a minor deviation from the enrollment criteria. For example, the protocol may define that all women have a hemoglobin level of at least 12 g/dL and the Investigator may wish to enroll a subject who has been stable for several months with a hemoglobin of 11.9 g/dL. The Medical Monitor may grant this exception if he/she assesses that enrollment will not put the subject at risk and will not affect the safety and efficacy assessments for the study. Any exemptions must be recorded in the study record and reported later in the Clinical Study Report. Only the Medical Monitor can grant exemptions.
The Medical Monitor will talk to the Investigator about any Serious Adverse Event to gather pertinent details, to discuss the Investigator's assessment of relationship to the study drug, and to write the SAE narrative for regulatory submission and submission to the Investigator's IRB. The Medical Monitor must assess whether a death or SAE requires interruption or discontinuation of the study.
The Medical Monitor may interact with FDA staff to discuss protocol design or safety monitoring during planned FDA meetings or may need to call FDA monitors to report unexpected serious adverse events. The Medical Monitor may talk to FDA staff to answer questions that arise when they are reviewing an Annual Report or an NDA submission.
Medical Monitors help the Clinical Research Associates and other study team members understand the complexities of the disease being studied.
Medical Monitors may meet with company Executives to explain the protocol design and and interpret safety or efficacy findings.
Medical Monitors review all safety and laboratory data submitted during the study. The Medical Monitor usually interacts directly with the Investigators to assess serious events or events that require that a subject interrupt dosing or be terminated from the study. The Medical Monitor completes all SAE reports and may need to contact the FDA in case of a serious, unexpected life-threatening event.
The Medical Monitor also reviews site visit reports from the CRAs and oversees the general progress of the study. The Medical Monitor may need to suggest protocol changes if unexpected safety problems arise, or if the sites are having difficulty completing study procedures.
Medical Monitors work with staff from Biostatistics and Data Management to design the tables, figures, and listings for the statistical analysis. Then, at the during the interim or final analysis, the Medical Monitor reviews all efficacy and safety data and oversees the coding of adverse events and medications. The Medical Monitor usually plays a major role in the preparation of the Clinical Study Report (CSR) and is usually one of the signatories for the CSR.
For more information about the role of Medical Monitors you may want to look at the Clinical Research section of our other website www.BioPharm-Medicine.com
Medical Monitors provide medical supervision of the clinical trial on behalf of the Sponsor. They do not actually conduct the study, that is the job of the Clinical Investigator. They may be employees of the Sponsor; may work for a Contract Research Organization (CRO), or may be freelance consultants.
Medical Monitors usually work with outside medical experts, Biostatisticians, Regulatory Affairs and Product Development staff to develop the study protocol. They review related literature to determine what type of efficacy assessments will be suitable. They work with the Biostatistician to determine sample size for the study based on the magnitude and variation of clinical effect expected. They usually collaborate with Data Management to design or review, the case report form templates.
The Medical Monitor works with the Sponsor’s pharmacologists and toxicologists and Regulatory Affairs to prepare the Investigator’s Brochure supplied to each Investigator.
Medical Monitors will interact with the the Clinical Investigators. The Investigators are responsible for selecting, treating and evaluating the subjects enrolled at their site. The Medical Monitor is responsible for overseeing the safety of all of the subjects at all of the sites; but the Medical Monitor does not directly participate in their care.
When designing the study and writing the protocol, the Monitor may consult with some of the Investigators who are experts in the disease being studied.
The Medical Monitor usually meets with all of the Investigators at the Investigator's Meeting to discuss the protocol and discuss how study assessments will be done.
The Medical Monitor monitor enrollment to ensure that only appropriate subjects are enrolled. Sometimes, an Investigator requests permission to enroll a subject who has a minor deviation from the enrollment criteria. For example, the protocol may define that all women have a hemoglobin level of at least 12 g/dL and the Investigator may wish to enroll a subject who has been stable for several months with a hemoglobin of 11.9 g/dL. The Medical Monitor may grant this exception if he/she assesses that enrollment will not put the subject at risk and will not affect the safety and efficacy assessments for the study. Any exemptions must be recorded in the study record and reported later in the Clinical Study Report. Only the Medical Monitor can grant exemptions.
The Medical Monitor will talk to the Investigator about any Serious Adverse Event to gather pertinent details, to discuss the Investigator's assessment of relationship to the study drug, and to write the SAE narrative for regulatory submission and submission to the Investigator's IRB. The Medical Monitor must assess whether a death or SAE requires interruption or discontinuation of the study.
The Medical Monitor may interact with FDA staff to discuss protocol design or safety monitoring during planned FDA meetings or may need to call FDA monitors to report unexpected serious adverse events. The Medical Monitor may talk to FDA staff to answer questions that arise when they are reviewing an Annual Report or an NDA submission.
Medical Monitors help the Clinical Research Associates and other study team members understand the complexities of the disease being studied.
Medical Monitors may meet with company Executives to explain the protocol design and and interpret safety or efficacy findings.
Medical Monitors review all safety and laboratory data submitted during the study. The Medical Monitor usually interacts directly with the Investigators to assess serious events or events that require that a subject interrupt dosing or be terminated from the study. The Medical Monitor completes all SAE reports and may need to contact the FDA in case of a serious, unexpected life-threatening event.
The Medical Monitor also reviews site visit reports from the CRAs and oversees the general progress of the study. The Medical Monitor may need to suggest protocol changes if unexpected safety problems arise, or if the sites are having difficulty completing study procedures.
Medical Monitors work with staff from Biostatistics and Data Management to design the tables, figures, and listings for the statistical analysis. Then, at the during the interim or final analysis, the Medical Monitor reviews all efficacy and safety data and oversees the coding of adverse events and medications. The Medical Monitor usually plays a major role in the preparation of the Clinical Study Report (CSR) and is usually one of the signatories for the CSR.
For more information about the role of Medical Monitors you may want to look at the Clinical Research section of our other website www.BioPharm-Medicine.com