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Clinical research regulations and good clinical practices

A M Clinical Research Topics Professional Englisch 163 Karten

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  1. 1Who is the sponsor?The sponsor is the entity who takes responsibility for and initiates a clinical investigation.
  2. 2The sponsor can beany legal entity, including a company, an academic organization, or an individual.
  3. 3The intent of the sponsor's CTA/IND or ITA/IDE isto allow testing for marketing approval of the drug or device. These are generally considered commercial or corporate CTAs/INDs or ITAs/IDEs.
  4. 4Who funds the clinical research?The sponsor is often but not always the entity that sponsors the clinical research.
  5. 5A sponsor-investigator isan individual who both initiates and conducts the clinical investigation and under whose immediate direction the investigational device/drug is being administered, used or dispensed.
  6. 6Investigator-initiated or sponsor-investigator CTAs/INDs or ITAs/IDEsare those applications in which, usually, te intent of the sponsor-investigator CTA/IND or ITA/IDE is to gain scientific knowledge without seeking market approval for the drug or device.
  7. 7For drug trials in Canada, the responsibilities of a sponsor-investigator are outlined onAppendix 3 of the HC3011 form
  8. 8For drug trials in the US, thre responsibilities of an investigator are outlined inthe form FDA 1572
  9. 9In both the US and Canada, the sponsor-investigator also assumes the responsibilities ofthe sponsor
  10. 10Drug supplier/manufacturer roleIn addition to producing the drug, the company also supplies the investigator with the drug for use in the study.
  11. 11What kind of acitivity falls under the scope of "practice of medicine"?When the intent of the physician is to practice medicine and not clinical research. In this case, the use of the marketed drug/device by the physician for a non-approved Health Canada or FDA indication does not require the submission of a CTA/IND/ITA/IDE.
  12. 12In Canada, when a physician wants to study a new intended use for an approved drug, what needs to be done?A CTA must be filed and a NOL (No objection letter) must be obtained from Health Canada prior to study initiation.
  13. 13Review period after the CTA submission or a CTA Amendment is screened and acknowledged30 days
  14. 14During the review of the CTA or CTA Amendment, if questions are received from Health Canada a response is required within2 calendar days
  15. 15What happens in case a drug or device is developed by the investigator him/herself?An IND/IDE must always be submitted to the FDA before the study can begin. These are investigator-initiated or sponsor-investigator INDs/IDEs.
  16. 16Unlike the new drugs/devices developed by the investigator, not every study using an approved drug requiresa CTA/IND
  17. 17CTA stands forClinical trial Application - Canada
  18. 18Health Canada and the US Food and Drug Administration regulatedrugs, biologics and devices used in the diagnosis, mitigation, treatment, or prevention of diseases.
  19. 19Health Canada and FDA conduct a thorough review of drugs, biologics and medical devices, before granting approval for marketing in their respective countries, forsafety and effectiveness
  20. 20Before a product is marketed, the sponsor submits an application forapproval by the regulator.
  21. 21The application submitted by the sponsor to the regulator containsa proposed "package insert" which may also be referred to as "labeling"
  22. 22The package insert or labeling submitted by the sponsor to the regulator summarizeswhat the regulator has determined to be safe and effective use of the product.
  23. 23The regulatory approval decision is based uponbioresearch data generated and reported to the regulator by the sponsor to support the marketing approval of a product.
  24. 24ITAInvestigational testing authorization
  25. 25INDInvestigational new drug
  26. 26IDEInvestigational drug exemption
  27. 27For a drug/device/biologic that has not yet reached the marketplace or that studies a new use of the marketed product, research protocols are evaluated byFDA (US) and Health Canada (Canada)
  28. 28The regulator will allow human studies to proceed if it determines thatthe risk of exposure to the drug is reasonable.
  29. 29Determination of whether the risk of exposure to the drug is reasonable is based uponData from prior animal or human testing
    Methods of manufacturing
    Plans for testing and reporting significant toxicities
    A well-developed clinical research plan that minimizes risks to the subjects
  30. 30Clinical investigation of a marketed drug does not require a CTA/IND if the following conditions are met:The data will not be used to support a new indication, new labeling, or change in advertising.
    The research does not involve a route of administration/dosage level or subject population that significantly increases the risks of the drug product.
    The research is conducted in compliance with REB/IRB review and informed consent requirements.
    The research is conducted in compliance with requirements for promotion and sale.
  31. 31Sponsors must file applications to conduct clinical trials in the following phasesPhases 1 through 3 of drug development and comparative bioavailability trials. This includes applications to conduct clinical trials involving marketed products where the proposed use of the product is outside the parameters of the approved NOC or the DIN application, US FDA 21CFR312.2(b)
  32. 32In the US, exemption from IND submission requirements does not mean exemption fromIRB review and approval or form informed consent from subjects. The FDA should be consulted if there are any changes.
  33. 33CTSIClinical Trial Site Information
  34. 34CTSI form must be submitted foreach proposed clinical trial site. Only completed forms should be submitted as a part of the CTA
  35. 35For all the clinical trial site information that becomes available after the time of applicationa completed Clinical Trial site information form must be provided to the appropriate Directorate, prior to the commencement of the clinical trial at that site.
  36. 36Form 1572 outlinesthe commitments that must be made by the investigator(s) regarding the conduct of the study.
  37. 37Form 1572 must listco-investigators who will be administering the drug or separate forms need to be submitted for these individuals.
    the IRB record for that study site
  38. 38Who MUST sign Form 1572Investigators participating in drug and biologic studies subject to the IND regulations
  39. 39The sponsor's responsibilities includeSelecting clinical investigators qualified by training and experience
    Informing and qualifying investigators by obtaining their commitment to supervise the study, follow the protocol, and obtain consent
    Monitoring the conduct of the study by auditing documentation and conducting site visits
    Completing regulatory filings related to the CTA/ITA or IND/IDE, adverse events, amendments or revisions, progress reports, withdrawal of IRB/REB approval and final reports.
    Controlling the distribution, tracking, and dispensation of the regulated products.
  40. 40Investigator responsibilities include (1)Ensuring REB/IRB approval for the study is obtained before any subjects are enrolled.
    Ensuring that informed consent is obtained in accordance with Health Canada/FDA regulations.
    Ensuring that the investigation is conducted according to the investigational plan and applicable regulations.
  41. 41Investigator responsibilities include (2)Administering the drug or using the device only in subjects under the investigator's supervision or under the supervision of a recognized subinvestigator.
    Maintaining adequate records of the dispensation of the drug or device.
    Returning unused materials at the end of the trial.
  42. 42Investigator responsibilities include (3)Preparing and maintaining adequate case histories and signed informed consent documents.
    Maintaining correspondence with the IRB and the sponsor to make sure that both have reviewed protocol amendments, recruiting materials, and investigator brochures.
  43. 43Investigator responsibilities include (4)Retaining records in accordance with regulations.
    Providing progress, safety, final and financial disclosure reports.
    Notifying the sponsor if REB/IRB approval is withdrawn.
    Comply with ICH guidelines, if applicable (Canada) - see conference of harmonization for guidance.
  44. 44Good clinical practicesets the standard for design, conduct, monitoring and reporting of clinical research.
  45. 45Compliance with GCP standards assuresthat human subjects will be adequately protected
    that the data submitted to regulators with the applications to market investigational products are accurate and credible
  46. 46ICH and full nameinternational conference on harmonization of technical requirements for registration of pharmaceuticals for human use
  47. 47Goal of ICHstandardize technical guidelines and requirements for drug marketing registrations, so that applications for marketing to various regulatory agencies around the world can occur without redundant testing.
  48. 48Why ICH?Repetition of clinical trials because of varying GCP standards.
    Costly, time-consuming for manufacturers in bringing new products to the market.
    Poor design and conduct resulting constituting an unethical use of human subjects in research.
  49. 49The working groups of ICH have representatives from 6 regulatory and pharmaceutical industry groupsEuropean Commission
    European Federation of Pharmaceutical Industries' Association (EFPIA)
    Ministry of Health and Welfare (Japan)
    Japan Pharmaceutical Manufacturers Association
    US FDA
    Pharmaceutical Research and manufacturing of America (PhRMA)
  50. 50Observers for ICHHealth Canada
    WHO
    European Free Trade Area (represented by Swissmedic)
  51. 51ICH is governed by and supported bygoverned by a Steering Committee and supported by the ICH Secretariat. The International Federation of Pharmaceutical Manufacturers Association (IFPMA) provides the Secretariat of the ICH and supports the Steering Committee.
  52. 52Steering committee compositionEach of the original groups has 2 seats on the committee
    IFPMA participates as a nonvoting member
  53. 53The observer groupsnominate other nonvoting participants to attend ICH Steering Committee meetings
  54. 54ICH topics and guidelinesfall into 4 main categories:
    1. Quality (Q) Topics relating to chemical and pharmaceutical QA
    2. Safety (S) Topics relating to in vitro and in vivo preclinical research
    3. Efficacy (E) Topics relating to research in human subjects
    4. Multidisciplinary (M) topics relating to topics that uniquely fit into one of the categories above.
  55. 55M topicsM1: Medical Terminology (MedDRA)
    M2: Electronic Stds for Transmission of Regulatory Info (ESTRI)
    M3: Timing of pre-clinical studies in relation to clinical trials
    M4: The Common Technical Document (CTD)
    M5: Data Elements and Stds for Drug Dictionaries
  56. 56Development of ICH standards involvesthe Steering Committee and "expert working groups."
  57. 57The expert working groups are responsiblefor developing specific guidelines. The ICH then provides an efficient process and format to standardize the new requirements across agencies and countries.
  58. 58E6 topic of the ICH guidelinespertains specifically to the conduct of clinical research to support marketing applications for drugs. It is one of over 200 guidance documents issued in this process.
  59. 59E6 defines GCP in a mannerconsistent with the Declaration of Helsinki (as an international and ethical standard)
  60. 60E6 also providesa unified standard for designing, conducting, recording, and reporting research involving human subjects.
  61. 61The 2 important goals of the E6 ICH standard areTo assure that the rights, well-being, and confidentiality of trial participants are protected
    To assure that the trial data are credible
  62. 62Health Canada adopted the E6 guideline in1997, incorporating editorial changes in both English and French versions. Canadian researchers should refer to one of these versions, rather than the original guideline on the ICH website.
  63. 63How many sections are there as part of the ICH GCP E6 GuidelineIntroduction plus 8 sections
  64. 64ICH GCP E6 Guideline IntroductionDescribes the purpose of GCP as an international std and orients the reader to the objecives and development process of ICH.
  65. 65ICH GCP E6 Guideline Section 1Glossary: a comprehensive glossary of terms that are used in the Guidelines and that are integral to clinical research.
  66. 66ICH GCP E6 Guideline Section 2The Principles of ICH GCP: is a detailed discussion of the objectives of establishing international ethical principles and quality standards in the conduct of clinical research, specifically for studies of investigational products that will support marketing applications. The predominant theme is protecting human subjects.
  67. 67ICH GCP E6 Guideline Section 3Institutional review Board/Independent Ethics Committee (IRB/IEC): REB's/IRBs are review boards that oversee research involving human subjects to assure the protection of their rights, safety, and welfare. Specific duties and responsibilities of REBs/IRBs/IECs are the focus of this section.
  68. 68ICH GCP E6 Guideline Section 4Investigator obligations
  69. 69ICH GCP E6 Guideline Section 5Sponsor requirements
  70. 70ICH GCP E6 Guideline Section 6Clinical Trial Protocol and Protocol Amendment (s) includes specific content standards for clinical trial protocols
  71. 71ICH GCP E6 Guideline Section 7Investigator's Brochure: section includes specific content stds for the INvestigator's Brochure, which details known information about an investigational product.
  72. 72ICH GCP E6 Guideline Section 8Essential documents for the Conduct of a Clinical Trial: summarizes the requirements for the documents that are essential to permit evaluation of the conduct of a trial and the quality of the data produced.
  73. 73Pertinent ICH Documents (other than E6 guidlelines)ICH E2A, Clinical safety data management: definitions and stds for expedited reporting: this doc applies to the requirements for assessing safety in clinical research and focuses on the responsibilities of the sponsor for reporting adverse events.
    ICH E8, Guidance on General considerations for Clinical Trials: this doc describes the drug development process and ICH expectations for establishing the safety and efficacy of new investigational agents.
  74. 74When does the ICH guideline apply?Widely recognized as International std for conducting clinical research. Basic principles can be applied to all research involving human subjects.
  75. 75For compliance for research sites outside of CanadaThe sponsor of the research should inform the site whether strict compliance with ICH GCP guidelines is required by local regulation.
  76. 76For drug studies conducted under a Canadian Trial Application (CTA), adherence to GCP is expected, but in case of discrepancythe regulations take precedence.
  77. 77For studies conducted under a US IND or IDE the research must comply with thecode of federal regulations (CFR), which represents US law. The ICH GCP standards are considered a guidance document by the FDA.
  78. 78How do Health Canada Regulations, US FDA regulations and ICH guidelines differ?In Canadian or US federal regulations, ICH GCP guidelines are not codified.
    In Canada, The Food and Drug Regulations, Part C, Division 5 regulations state that in case of discrepancy the regulation takes precedence.
    FDA regulations have been revised to be more consistent with the ICH requirements - no contradiction. Still some differences that need to be appreciated by the investigators.
  79. 79Boundaries for best practiceComplying completely with ICH GCP requirements, while allowing for some differences between Health Canada and FDA regulations, does not in any way violate either country's regulations, and constitutes best practice.
  80. 80To supplement the published FDA and Health Canada regulationsguidance documents and information sheets are provided by both bodies.
  81. 81Pharmacokineticsdescribes how the agent moves through and is excreted from the body
  82. 82Pharmacodynamicsdescribes the effects of the agent while in the body.
  83. 83Bioavailabilityis the degree to which, or the rate at which, a medication or other substance is absorbed or becomes available at the targeted place in the body.
  84. 84Controlled meansthat subjects are split into at least two groups: those receiving the experimental agent and those receiving a std treatment for the condition (an active control), no treatment, or a placebo. If subjects are assigned randomly into these groups, the study is a randomized trial.
  85. 85In Canada, the Food and Drug Regulations, Part C, Division 5apply for the purpose of conducting a clinical study for a drug.
  86. 86In the US, the Code of Federal Regulations (CFR) indicates that"the purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous change in the course of disease, placebo effect, or biased observation
  87. 87To provide Health Canada and/or the US FDA with the requested evidence, a sponsor seeks to show safety and efficacy of a new drug byDefining routes of administration and dosing frequencies
    Testing drug formulations
    Exploring combination and adjuvant therapies
    Assessing the pharmacokinetics and pharmacogenomics of the agent
    Evaluating the effect of the drug or device on the subject's quality of life
  88. 88Unlike the US IND process, in Canada each studyis considered its own CTA. Including applications to conduct trials involving marketed products where the proposed use of the pdt is outside the parameters of the NOC or DIN (e.g. new indication or unauthorized dose).
  89. 89Initiation of a clinical trial at the Canadian site requires approval fromboth Health Canada and the clinical site REB (+ CTSI prior to commencement)
  90. 90Conduct of Phase 4 clinical trials must be in accordance withGCP
  91. 91It is illegal to give an experimental article to a human being according tothe US Food, Drug and Cosmetic Act.
  92. 92The IND application includesForm FDA 1571 and all known information about the investigational product, such as the results of the clinical trials
  93. 93The Sponsor must maintain a current IND application throughout each clinical trial byamending the IND with a new Form FDA 1571 and providing the following information:
    Safety updates
    Copies of new protocols
    Form FDA 1572, Statement of Investigator: the document that notifies FDA of relevant changes in investigators conducting clinical trials under the IND, and,
    Annual Progress Reports.
  94. 94Preclinical studies refers tothe first step in the drug development process that allows investigators to evaluate the drug using tissue cultures and animal models. The drug's activity, for eg, its pharmacokinetics and bioavailability, also is estd in animal models. (Safety and promise of effectiveness) 3-6 yrs
  95. 95Time taken by Health Canada to review the CTA and evalutate the data to determine whether the study can be conducted in human subjects30 days
  96. 96Upon approval of the study (CTA)NOL will be issued by Health Canada
  97. 97An Information Request will be issued by Health Canada ifHealth Canada has questions during the review of the CTA
  98. 98How does health Canada send the Information RequestTypically by fax, maybe even Email or phone
  99. 99In response to an Information Request, Health Canada needs to respondwithin 2 calendar days, with a written response.
  100. 100If Health Canada deems the study to be unsafea Not Satisfactory Notice (NSN) will be issued and the study may not be conducted at Canadian sites.
  101. 101Will Health Canada always send out a notification to the Sponsor withing 30 days of submission?No, not necessarily.
  102. 102If the 30 day default review period passes without notification from Health Canadathe sponsor is free to proceed with obtaining REB approval and conducting the study. Although not required by regulation, it is considered "Best Practice" for the sponsor to contact Health Canada prior to starting the study.
  103. 103After the study has received approval, should changes be made to any of the information within the original CTA submission thena notification (minor admin changes, filed within 15 days of implementation) or an amendment (changes affect the selection, monitoring of patients and/or safety and efficacy evaluation of the drug, requiring a formal 30 day approval with a new NOL issued by Health Canada) mus be submitted to Health Canada and REB/IRB.
  104. 104The only exception to the requirement for pre-approval of CTA amendments is due toa serious safety concern. In order to protect study subjects, an amendment to the protocol may be implemented immediately, followed by prompt submission of the amendment to Health CAnada by the sponsor.
  105. 105Analog of CTA in the US isIND, 30 day review by FDA, best practice to notify before beginning research/recruitment (NSN type document?)
  106. 106Phase 1 goals and subject populationAssess toxicity
    Determine drug's pharmacokinetic and pharmacodynamic profiles
    Determine doses resulting in sufficient biological level of drug.
    Normal, healthy volunteers. If drug toxicity prevents exposure, patients with end-stage disease might be enrolled.
  107. 107Phase 2 goals and subject populationDetermine drug's short-term risks (SAFETY) - PRIMARY GOAL
    Examine preliminary effectiveness of drug
    Controlled studies enrolling limited numbers of patients
  108. 108Phase 3 goals and subject poplulationDetermine drug's EFFECTIVENESS (PRIMARY GOAL)
    Determine long-term drug safety
    Confirm phase 2 findings
    Controlled and uncontrolled studies (but typically placebo-controlled and double-blinded) enrolling larger patient numbers and seeking to confirm results of Phase 2 trials.
  109. 109Which submission (data obtained to provide evidence of safety and efficacy) requests permission to market the product?NDS (New Drug Submission) in Canada and New Drug Approval (NDA) in the US.
  110. 110NDS or NDA review typically takes6 months to 2 years
  111. 111What is the Investigator's Brochure (IB)?A compilation of the pre-clinical and clinical data on the investigational product (s) that are relevant to the study of the product (s) in human subjects.
  112. 112What is the purpose of the IB?Provide the investigators and others involved in the trial with the information to help them understand the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration, and safety monitoring procedures (ICH GCP Guideline E6 [7.1]).
  113. 113The IB is generated initially from thepreclinical data. As new, relevant data are generated during drug development, the iB is updated. The sponsor is responsible for initiating and updating the IB and making it available to investigators participating in clinical studies of their product(s).
  114. 114QIUQualified Investigator Undertaking form
  115. 115CRFCase Report Forms
  116. 116SAESerious adverse event
  117. 117Investigators should report to the Ethics committee: New information that may affect adversely the safety of the subjects or theconduct of trial or that may impact the subject's willingness to continue in a study
  118. 118According to ICH GCP what should the investigator, or person designated by the investigator, do for deviations from the protocol?Document and explain them.
  119. 119MAHMarketing Authorization Holder
  120. 120If compliance is poor, that meansthe subject is not taking the IP as is recommended by the PI's instructions.
  121. 121CAPACorrective and Preventative actions
  122. 122Is every ICH GCP deviation a protocol deviation?No
  123. 123Is every protocol deviation an ICH GCP deviation?yes
  124. 124Minor protocol deviationAffects study assesments
  125. 125Major protocol deviationInclusion or exclusion criteria are not met
  126. 126Protocol violationare the deviations that lead to an SAE (serious adverse event)
  127. 127What is a clinical study report?A written description of a trial/study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects, in which the clinical and statistical description, presentations, and analyses are fully integrated into a single report.
  128. 128The integrated full report of a study (clinical study report) should not be derived by simply joininga separate clinical and
    statistical report.
  129. 129The investigator should ensure that the investigational product(s) are used only in accordance withthe approved protocol
  130. 130Who submits written summaries of the trial status to the IRB/IEC annually, or more frequently, if requested by the IRB/IEC ?The investigator
  131. 131The investigator provides evidence of his/her qualifications to perform the research throughup-to-date curriculum vitae or other relevant documentation requested by the sponsor, IRB
    or regulatory authority.
  132. 132The investigator is familiar with the appropriate use of the investigational product(s), as described inthe protocol, in the current investigator’s brochure, in the product information
    and in other information sources provided by the sponsor.
  133. 133The investigator conducts the research in accordance withthe signed agreement with the
    sponsor, applicable regulatory requirements and the requirements of the IRB.
  134. 134The investigator shall permit investigational product(s) to be used with subjects only underthe investigator’s supervision and will not provide the investigational product(s to any
    unauthorized persons.
  135. 135The investigator shall maintain accurate, complete, and current records, including aspects as relevant to the research:All correspondence with other investigators, IRB, sponsor, monitors, or regulatory
    authority(ies).
    The receipt, use or disposition of investigational product(s).
    Records of each subject’s case history and exposure to the investigational product(s).
    Reasons for each deviation from the protocol, regulatory requirements, or IRB
    requirements.
    Any other records required by the IRB or regulatory authority(ies).
  136. 136The investigator shall obtain consent from each subject as follows, except for research involving a waiver of consent that has been approved by the IRB:Consent is obtained from each subject before initiating any research-specific
    procedures.
    o To the extent possible, the investigator should ensure that the subject understands
    the information about the research in order to provide informed consent.
    o To the extent possible, the investigator should ensure that the subject can consent
    free from coercion or other undue influence.
    o When individuals have signed a research directive indicating their preferences about
    future participation in research in the event that they lose capacity or upon death, the
    investigator and legally authorized representatives should be guided by these
    directives during the consent process
  137. 137Is the subject obliged to give his or her reasons for withdrawing prematurely from the clinical trial ?No. However, the investigator should make a reasonable effort to ascertain the
    reason, while fully respecting the subject’s rights
  138. 138The investigator reports serious adverse events to the sponsor except for those eventsthat
    the protocol or other document (e.g., investigator’s brochure) identifies as not needing
    immediate reporting.
  139. 139If the IRB terminates or suspends its approval of the research thenthe investigator should
    promptly notify the sponsor.
  140. 140The investigator maintains a list of appropriately qualified personsto whom the investigator
    has delegated significant research-related duties.
  141. 141Is the investigator expected to understand law? If yes, by whom?IRB Services expects investigators to understand local laws and special considerations for studies
    involving children or other populations requiring a guardian or legally authorized representative
    (LAR). IRB Services expects the investigator to notify us if local or provincial/state laws
    require any modifications to the language or signature block of consent documentation.
  142. 142LARLegally authorized representative
  143. 143Which are the 3 IND types?Investigator IND, Emergency use IND, and treatment IND
  144. 144Investigator INDis submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed. A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population.
  145. 145Emergency use INDallows the FDA to authorize use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with 21CFR , Sec. 312.23 or Sec. 312.34. It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist.
  146. 146Treatment INDis submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.
  147. 147Which are the 2 IND categories?research and commercial
  148. 148Who is responsible for implementing and maintaining quality assurance and quality control systems with written SOPs to ensure that trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s)?Sponsor
  149. 149Who is responsible for securing agreement from all involved parties to ensure direct access to all trial- related sites, source data/documents, and reports for the purpose of monitoring and auditing by the sponsor, and inspection by domestic and foreign regulatory authorities?The Sponsor
  150. 150What should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly?QC
  151. 151Who is responsible for the quality and integrity of the trial data?The Sponsor
  152. 152Who should designate appropriately qualified medical personnel who will be readily available to advise on trial-related medical questions or problems?The Sponsor. If necessary,
    outside consultant(s) may be appointed for this purpose.
  153. 153IDMCIndependent Data monitoring committee
  154. 154What is an IDMC and who may set one up?The sponsor may consider establishing an independent data monitoring
    committee (IDMC) to assess the progress of a clinical trial, including the safety
    data and the critical efficacy endpoints at intervals, and to recommend to the
    sponsor whether to continue, modify, or stop a trial. The IDMC should have
    written operating procedures and maintain written records of all its meetings
  155. 155Unexpectedas used in the SUSARS definition, refers to any adverse event that is not in the Investigator's Brochure or current sponsor's protocol, even if it might be reasonably anticipated based on a product's pharmacological properties.
  156. 156DisabilityA substantial disruption of a person's ability to conduct normal life functions.
  157. 157Life-threatening adverse drug experienceAny adverse drug experience that places the subject, in the view of the investigator, at immediate risk of death from the reaction as it occurred, that is, it does not include reactions that, had they occurred in more severe forms, might have caused death.
  158. 158ICH GCP states: " An investigator shall promptly report to the sponsorany adverse effect that may reasonably be regarded as caused by, or probably caused by, the drug. If the adverse effect is alarming, the investigator shall report the adverse effect immediately."
  159. 159The industry standard is to report all SAEs within24 hours of their identification. If the event is life-threatening or fatal, the event should be reported immediately.
  160. 160The reporting requirements for reporting any adverse effect are spelled outclearly by the sponsor in the protocol. The sponsor will outline in the protocol the criteria and process for reporting all AEs, including those that are serious.
  161. 161SAEs are recorded onthe relevant Case Report Form page unless otherwise directed by the sponsor.
  162. 162Form FDA 3500 A is theMedWatch Mandatory Reporting form.
  163. 163Information to include in SAE ReportsDemographic data, patient details; Product information; Other treatments; Details of the suspected adverse event; Treatment of event; Outcome; Details of person submitting the report; Administrative and sponsor information

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Professional Clinical Research Topics (Clinical Research) Karteikarten am Clinical research regulations and good clinical practices , erstellt von A M am 15/07/2015.
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