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| Pregunta | Respuesta |
| Who is the sponsor? | The sponsor is the entity who takes responsibility for and initiates a clinical investigation. |
| The sponsor can be | any legal entity, including a company, an academic organization, or an individual. |
| The intent of the sponsor's CTA/IND or ITA/IDE is | to allow testing for marketing approval of the drug or device. These are generally considered commercial or corporate CTAs/INDs or ITAs/IDEs. |
| Who funds the clinical research? | The sponsor is often but not always the entity that sponsors the clinical research. |
| A sponsor-investigator is | an individual who both initiates and conducts the clinical investigation and under whose immediate direction the investigational device/drug is being administered, used or dispensed. |
| Investigator-initiated or sponsor-investigator CTAs/INDs or ITAs/IDEs | are 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. |
| For drug trials in Canada, the responsibilities of a sponsor-investigator are outlined on | Appendix 3 of the HC3011 form |
| For drug trials in the US, thre responsibilities of an investigator are outlined in | the form FDA 1572 |
| In both the US and Canada, the sponsor-investigator also assumes the responsibilities of | the sponsor |
| Drug supplier/manufacturer role | In addition to producing the drug, the company also supplies the investigator with the drug for use in the study. |
| What 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. |
| In 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. |
| Review period after the CTA submission or a CTA Amendment is screened and acknowledged | 30 days |
| During the review of the CTA or CTA Amendment, if questions are received from Health Canada a response is required within | 2 calendar days |
| What 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. |
| Unlike the new drugs/devices developed by the investigator, not every study using an approved drug requires | a CTA/IND |
| CTA stands for | Clinical trial Application - Canada |
| Health Canada and the US Food and Drug Administration regulate | drugs, biologics and devices used in the diagnosis, mitigation, treatment, or prevention of diseases. |
| Health Canada and FDA conduct a thorough review of drugs, biologics and medical devices, before granting approval for marketing in their respective countries, for | safety and effectiveness |
| Before a product is marketed, the sponsor submits an application for | approval by the regulator. |
| The application submitted by the sponsor to the regulator contains | a proposed "package insert" which may also be referred to as "labeling" |
| The package insert or labeling submitted by the sponsor to the regulator summarizes | what the regulator has determined to be safe and effective use of the product. |
| The regulatory approval decision is based upon | bioresearch data generated and reported to the regulator by the sponsor to support the marketing approval of a product. |
| ITA | Investigational testing authorization |
| IND | Investigational new drug |
| IDE | Investigational drug exemption |
| For 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 by | FDA (US) and Health Canada (Canada) |
| The regulator will allow human studies to proceed if it determines that | the risk of exposure to the drug is reasonable. |
| Determination of whether the risk of exposure to the drug is reasonable is based upon | Data 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 |
| Clinical 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. |
| Sponsors must file applications to conduct clinical trials in the following phases | Phases 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) |
| In the US, exemption from IND submission requirements does not mean exemption from | IRB review and approval or form informed consent from subjects. The FDA should be consulted if there are any changes. |
| CTSI | Clinical Trial Site Information |
| CTSI form must be submitted for | each proposed clinical trial site. Only completed forms should be submitted as a part of the CTA |
| For all the clinical trial site information that becomes available after the time of application | a completed Clinical Trial site information form must be provided to the appropriate Directorate, prior to the commencement of the clinical trial at that site. |
| Form 1572 outlines | the commitments that must be made by the investigator(s) regarding the conduct of the study. |
| Form 1572 must list | co-investigators who will be administering the drug or separate forms need to be submitted for these individuals. the IRB record for that study site |
| Who MUST sign Form 1572 | Investigators participating in drug and biologic studies subject to the IND regulations |
| The sponsor's responsibilities include | Selecting 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. |
| Investigator 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. |
| Investigator 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. |
| Investigator 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. |
| Investigator 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. |
| Good clinical practice | sets the standard for design, conduct, monitoring and reporting of clinical research. |
| Compliance with GCP standards assures | that human subjects will be adequately protected that the data submitted to regulators with the applications to market investigational products are accurate and credible |
| ICH and full name | international conference on harmonization of technical requirements for registration of pharmaceuticals for human use |
| Goal of ICH | standardize 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. |
| Why 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. |
| The working groups of ICH have representatives from 6 regulatory and pharmaceutical industry groups | European 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) |
| Observers for ICH | Health Canada WHO European Free Trade Area (represented by Swissmedic) |
| ICH is governed by and supported by | governed 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. |
| Steering committee composition | Each of the original groups has 2 seats on the committee IFPMA participates as a nonvoting member |
| The observer groups | nominate other nonvoting participants to attend ICH Steering Committee meetings |
| ICH topics and guidelines | fall 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. |
| M topics | M1: 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 |
| Development of ICH standards involves | the Steering Committee and "expert working groups." |
| The expert working groups are responsible | for developing specific guidelines. The ICH then provides an efficient process and format to standardize the new requirements across agencies and countries. |
| E6 topic of the ICH guidelines | pertains 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. |
| E6 defines GCP in a manner | consistent with the Declaration of Helsinki (as an international and ethical standard) |
| E6 also provides | a unified standard for designing, conducting, recording, and reporting research involving human subjects. |
| The 2 important goals of the E6 ICH standard are | To assure that the rights, well-being, and confidentiality of trial participants are protected To assure that the trial data are credible |
| Health Canada adopted the E6 guideline in | 1997, 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. |
| How many sections are there as part of the ICH GCP E6 Guideline | Introduction plus 8 sections |
| ICH GCP E6 Guideline Introduction | Describes the purpose of GCP as an international std and orients the reader to the objecives and development process of ICH. |
| ICH GCP E6 Guideline Section 1 | Glossary: a comprehensive glossary of terms that are used in the Guidelines and that are integral to clinical research. |
| ICH GCP E6 Guideline Section 2 | The 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. |
| ICH GCP E6 Guideline Section 3 | Institutional 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. |
| ICH GCP E6 Guideline Section 4 | Investigator obligations |
| ICH GCP E6 Guideline Section 5 | Sponsor requirements |
| ICH GCP E6 Guideline Section 6 | Clinical Trial Protocol and Protocol Amendment (s) includes specific content standards for clinical trial protocols |
| ICH GCP E6 Guideline Section 7 | Investigator's Brochure: section includes specific content stds for the INvestigator's Brochure, which details known information about an investigational product. |
| ICH GCP E6 Guideline Section 8 | Essential 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. |
| Pertinent 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. |
| When 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. |
| For compliance for research sites outside of Canada | The sponsor of the research should inform the site whether strict compliance with ICH GCP guidelines is required by local regulation. |
| For drug studies conducted under a Canadian Trial Application (CTA), adherence to GCP is expected, but in case of discrepancy | the regulations take precedence. |
| For studies conducted under a US IND or IDE the research must comply with the | code of federal regulations (CFR), which represents US law. The ICH GCP standards are considered a guidance document by the FDA. |
| How 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. |
| Boundaries for best practice | Complying 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. |
| To supplement the published FDA and Health Canada regulations | guidance documents and information sheets are provided by both bodies. |
| Pharmacokinetics | describes how the agent moves through and is excreted from the body |
| Pharmacodynamics | describes the effects of the agent while in the body. |
| Bioavailability | is 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. |
| Controlled means | that 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. |
| In Canada, the Food and Drug Regulations, Part C, Division 5 | apply for the purpose of conducting a clinical study for a drug. |
| In 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 |
| To provide Health Canada and/or the US FDA with the requested evidence, a sponsor seeks to show safety and efficacy of a new drug by | Defining 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 |
| Unlike the US IND process, in Canada each study | is 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). |
| Initiation of a clinical trial at the Canadian site requires approval from | both Health Canada and the clinical site REB (+ CTSI prior to commencement) |
| Conduct of Phase 4 clinical trials must be in accordance with | GCP |
| It is illegal to give an experimental article to a human being according to | the US Food, Drug and Cosmetic Act. |
| The IND application includes | Form FDA 1571 and all known information about the investigational product, such as the results of the clinical trials |
| The Sponsor must maintain a current IND application throughout each clinical trial by | amending 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. |
| Preclinical studies refers to | the 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 |
| Time taken by Health Canada to review the CTA and evalutate the data to determine whether the study can be conducted in human subjects | 30 days |
| Upon approval of the study (CTA) | NOL will be issued by Health Canada |
| An Information Request will be issued by Health Canada if | Health Canada has questions during the review of the CTA |
| How does health Canada send the Information Request | Typically by fax, maybe even Email or phone |
| In response to an Information Request, Health Canada needs to respond | within 2 calendar days, with a written response. |
| If Health Canada deems the study to be unsafe | a Not Satisfactory Notice (NSN) will be issued and the study may not be conducted at Canadian sites. |
| Will Health Canada always send out a notification to the Sponsor withing 30 days of submission? | No, not necessarily. |
| If the 30 day default review period passes without notification from Health Canada | the 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. |
| After the study has received approval, should changes be made to any of the information within the original CTA submission then | a 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. |
| The only exception to the requirement for pre-approval of CTA amendments is due to | a 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. |
| Analog of CTA in the US is | IND, 30 day review by FDA, best practice to notify before beginning research/recruitment (NSN type document?) |
| Phase 1 goals and subject population | Assess 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. |
| Phase 2 goals and subject population | Determine drug's short-term risks (SAFETY) - PRIMARY GOAL Examine preliminary effectiveness of drug Controlled studies enrolling limited numbers of patients |
| Phase 3 goals and subject poplulation | Determine 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. |
| Which 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. |
| NDS or NDA review typically takes | 6 months to 2 years |
| What 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. |
| What 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]). |
| The IB is generated initially from the | preclinical 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). |
| QIU | Qualified Investigator Undertaking form |
| CRF | Case Report Forms |
| SAE | Serious adverse event |
| Investigators should report to the Ethics committee: New information that may affect adversely the safety of the subjects or the | conduct of trial or that may impact the subject's willingness to continue in a study |
| According to ICH GCP what should the investigator, or person designated by the investigator, do for deviations from the protocol? | Document and explain them. |
| MAH | Marketing Authorization Holder |
| If compliance is poor, that means | the subject is not taking the IP as is recommended by the PI's instructions. |
| CAPA | Corrective and Preventative actions |
| Is every ICH GCP deviation a protocol deviation? | No |
| Is every protocol deviation an ICH GCP deviation? | yes |
| Minor protocol deviation | Affects study assesments |
| Major protocol deviation | Inclusion or exclusion criteria are not met |
| Protocol violation | are the deviations that lead to an SAE (serious adverse event) |
| What 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. |
| The integrated full report of a study (clinical study report) should not be derived by simply joining | a separate clinical and statistical report. |
| The investigator should ensure that the investigational product(s) are used only in accordance with | the approved protocol |
| Who submits written summaries of the trial status to the IRB/IEC annually, or more frequently, if requested by the IRB/IEC ? | The investigator |
| The investigator provides evidence of his/her qualifications to perform the research through | up-to-date curriculum vitae or other relevant documentation requested by the sponsor, IRB or regulatory authority. |
| The investigator is familiar with the appropriate use of the investigational product(s), as described in | the protocol, in the current investigator’s brochure, in the product information and in other information sources provided by the sponsor. |
| The investigator conducts the research in accordance with | the signed agreement with the sponsor, applicable regulatory requirements and the requirements of the IRB. |
| The investigator shall permit investigational product(s) to be used with subjects only under | the investigator’s supervision and will not provide the investigational product(s to any unauthorized persons. |
| The 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). |
| The 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 |
| Is 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 |
| The investigator reports serious adverse events to the sponsor except for those events | that the protocol or other document (e.g., investigator’s brochure) identifies as not needing immediate reporting. |
| If the IRB terminates or suspends its approval of the research then | the investigator should promptly notify the sponsor. |
| The investigator maintains a list of appropriately qualified persons | to whom the investigator has delegated significant research-related duties. |
| Is 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. |
| LAR | Legally authorized representative |
| Which are the 3 IND types? | Investigator IND, Emergency use IND, and treatment IND |
| Investigator IND | is 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. |
| Emergency use IND | allows 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. |
| Treatment IND | is 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. |
| Which are the 2 IND categories? | research and commercial |
| Who 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 |
| Who 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 |
| What should be applied to each stage of data handling to ensure that all data are reliable and have been processed correctly? | QC |
| Who is responsible for the quality and integrity of the trial data? | The Sponsor |
| Who 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. |
| IDMC | Independent Data monitoring committee |
| What 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 |
| Unexpected | as 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. |
| Disability | A substantial disruption of a person's ability to conduct normal life functions. |
| Life-threatening adverse drug experience | Any 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. |
| ICH GCP states: " An investigator shall promptly report to the sponsor | any 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." |
| The industry standard is to report all SAEs within | 24 hours of their identification. If the event is life-threatening or fatal, the event should be reported immediately. |
| The reporting requirements for reporting any adverse effect are spelled out | clearly 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. |
| SAEs are recorded on | the relevant Case Report Form page unless otherwise directed by the sponsor. |
| Form FDA 3500 A is the | MedWatch Mandatory Reporting form. |
| Information to include in SAE Reports | Demographic 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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