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Kent Associates, Inc clinical quality assurance consultants. Nov. Posted in Good Clinical Practice by admin . Goodson and Phyllis B. Kent. Risk- based monitoring (RBM) is no longer just a concept. FDA's support of RBM, as stated in the August 2. The traditional approach to monitoring has been to monitor frequently and conduct extensive source documentation verification of data to achieve the primary assurances of subjects' safety and data integrity. In contrast, the concept behind RBM is to modernize monitoring efforts by using electronic capabilities following study- specific monitoring plans with defined quality strategies to accomplish clinical trial efficiencies. The guidance promotes the need for an updated approach that includes a strong focus on critical study parameters, a combination of monitoring activities (on- site and remote), and development of stronger Monitoring Plans. The underlying premise of RBM is that the errors that are not identified and corrected through SDV do not substantially impact the overall conclusions. As set out in the ICH Harmonised Tripartite Guideline E9: Statistical Principles for Clinical. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Secretariat, Chemin Louis-Dunant 15, P.O. ICH E1 Population exposure: the extent of population exposure to assess clinical safety; ICH E2A Clinical safety data management: definitions and standards for. Clinical data validation is the process of reviewing clinical data for correctness and completeness. Background Induction of hypothermia in patients with brain injury was shown to improve outcomes in small clinical studies, but the results were not definitive. ![]() ![]() An example of one of the potential pitfalls in this philosophy is in the area of finding and reporting AE/SAE omissions or inclusion/exclusion omissions. Remote monitoring cannot find omissions from non- required fields (e. AEs, Concomitant medications, prior medical history). It can only detect omissions from required fields or inconsistencies on data entered. The detection of omissions will be a challenge for monitors and auditors without routinely reviewing charts and assessing entrance criteria. This paper will not debate the pros and cons of traditional monitoring vs. RBM, but rather offer points for consideration to ensure data quality as these new strategies and processes evolve. How often? Will SOPs be established for fraud detection programs? What processes are in place to evaluate suspicious results? Changes in Sponsor- CRO Responsibilities. What directives will Sponsors be providing to CROs? Will the Sponsor or the CRO be conducting the remote monitoring? Who will determine when errors are significant or numerous enough to expand the monitoring? Will the error rates be pre- defined? Furthermore, Sponsors delegate monitoring responsibilities to the CRO and oversight of the monitoring has not always been consistent. The RBM model, as noted in the FDA RBM Final Guidance, underscores the need for Sponsors to share internal risk assessment results with the CRO rather than just delegating monitoring responsibilities so that they can partner in a timely fashion, as significant remote monitoring findings potentially change the overall risk for a trial and subsequently site monitoring frequency. A review of Warning Letters in the last few years provides insight into the agency's stress on inadequate monitoring practices. In a well known case of a major pharmaceutical company, monitors were held accountable for not noting several instances of discrepancies between source records and the CRF for key study parameters. The concern is that limiting the amount of SDV performed will not preclude the agency's citing of inadequate monitoring should inspections result in uncovering these types of findings. This document is a revision of the Guidance for Industry: Financial Disclosure by Clinical Investigators dated March 2. The Financial Disclosure by Clinical Investigators regulation (2. CFR part 5. 4) requires applicants who submit a marketing application for a drug, biological product or device to submit certain information concerning the compensation to, and financial interests and arrangements of, any clinical investigator conducting clinical studies covered by the regulation. The regulation, which became effective on February 2, 1. FDA relies on to establish that the product is effective, and any study in which a single investigator makes a significant contribution to the demonstration of safety (2. CFR . The regulation requires applicants to certify the absence of certain financial interests and arrangements of clinical investigators that could affect the reliability of data submitted to FDA, or to disclose those financial interests and arrangements to the agency and identify steps taken to minimize the potential for bias (2. CFR . If the applicant does not include certification and/or disclosure, or does not certify that it was unable to obtain the information despite exercising due diligence, the agency may refuse to file the application (2. CFR . Although selection of clinical investigators and research sites, and determining if an investigational new drug application (IND) or investigational device exemption (IDE) is required are viewed primarily as sponsor responsibilities, FDA is issuing this guidance to clarify IRBs' responsibilities related to these activities and to encourage all parties to work together in order to protect the rights and welfare of study subjects. FDA has compiled the recommendations from these various sources into this guidance to ensure that all IRBs have access to it. In addition, FDA provides guidance on how IRBs may efficiently fulfill these important responsibilities. Kent The guidance on Section 1. List of Investigators does not specifically reference which address should be included. However, since the investigator’s institutional affiliation is requested, it appears that they are expecting the study site location, not just the investigator’s mailing address. FDA Form 1. 57. 2 contains the mailing address in Box 1. The institution and study site addresses are contained in Box 3. In order to conform to the guidance, the Box 3 information should be used. In the interest of full disclosure and traceability, if a site moved, the former address should be included and so indicated. In addition, since “affiliations” are specifically requested this would imply that multiple addresses should be reported if the study was conducted at more than one location. To ensure accountability for all sites, investigators who were submitted to FDA in an IND update should be included in the list, even if they did not enroll subjects. These can be footnoted to indicate lack of enrollment. Transfer of responsibility from one to PI to another should also be noted in the table. Some sponsors present the other significant persons, i. Transparency in this table eliminates potential discrepancy issues during Sponsor Bioresearch Monitoring inspections. The excerpt of the guidance is included below for reference. Guideline for Industry. Structure and Content of Clinical Study Reports. July 1. 99. 6ICH E3 Section 6“6. INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTUREThe administrative structure of the study (e. C. R. O.), clinical trial supply management) should be described briefly in the body of the report. There should be provided in Appendix 1. A similar list for other persons whose participation materially affected the conduct of the study should also be provided in Appendix 1. In the case of large trials with many investigators, the above information may be abbreviated to consist of general statements of qualifications for persons carrying out particular roles in the study with only the name, degree, and institutional affiliation and roles of each investigator or other participant. The listing should include: A. Investigators. B. Any other person carrying out observations of primary or other major efficacyvariables, such as a nurse, physician's assistant, clinical psychologist, clinical pharmacist,or house staff physician. It is not necessary to include in this list a person with only anoccasional role, e. May. Posted in Good Clinical Practice by admin . This final rule is based in part upon recommendations from the Government Accountability Office, and is intended to help ensure adequate protection of research subjects and the quality and integrity of data submitted to FDA. |
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