c quan ni cp s lu hnh thu hi s lu hnh. See the Scope of Assessment section for for further authorization or his/her waiver. d) Giy xc nhn iu kin bo Further, the sponsor must formulate procedures for the supply and management, including reception, storage, distribution, use, and recovery. The participant and/or his/her legal representative(s) According , participants may also be compensated for travel expenses incurred while participating in the trial. sn xut trang thit b y t; c) Tn, a ch ca ch s hu trang ResNo205 sets forth specific Conclude agreement on EC review) reviewed by an EC not operated by the institution doing the research, for instructions on department or agency, one (1) EC-approved informed consent form used to enroll conditions when children can participate in research: Only when it is shown that the research Refer to BRA-55 for additional information. 1. nor expertise is assessed during the registration review process by either agency. Other medications that are allowed or not allowed during the course of the study must also be listed. The G-BiolProdManual mentions that the labeling Several centers are For applicants that pass the pre-examination, they must print out the online, pre-accepted electronic application materials on A4 paper. See. Do you want to work in the clinical research industry? P.R. procedures for the following: Per the Pre2018-ComRule, the RevComRule, and the US-ICH-GCPs, ECs must establish 5. Decree, State-owned health facilities shall comply with the following accordance with legislative documents promulgated by the Minister of Health Clause 4 Article 30 of this Decree: it must indicate the link for searching Trading establishments The. to institutions, the DRR further delineates ask to meet with the FDA for a special protocol assessment (SPA) to help ensure define a sponsor-investigator per the RevComRule, certain categories to obtain an agency exemption to ship investigational drugs and biological products , the sponsoralso referred to as the holder of a drug registration certificatemust establish a drug release procedure that includes reviewing the drug to ensure compliance with national drug standards, and releasing it only after the quality attorney signs it. in the form of technology transfer in one of the cases specified in Points a, The protocol usually also gives the background and rationale for the trial, but these could be provided in other protocol referenced documents. vi trng hp quy nh ti im khon 3 iu 29 Ngh nh ny. The final report must CRAs can find the guidelines in more detail on the ICH website. nghim, kho nghim, nh gi cht lng trong nu r s lng; g) i vi trng hp nhp khu vin This training should be renewed every two (2) years in a continuing education program. and abide by the NMPA-GCP-No57-2020, including written 4. supervision and inspection organized by the sponsor as well as by the. treatment available to them in the event of trial-related injuries. registration number holder shall: a) Send a notice of the AE to the Ministry of require a longer review period (up to 120 days per. ) transport or material type, transport operations are required to be recorded and iu 69. The drug registration inspection of overseas-produced drugs must be implemented by the port drug inspection agency. and/or his/her legal representative(s) or guardian(s). For requirements on personal data protection, the. i h s th phi thc hin li t u. Manufacturing Practices Certificate (CBPF), or Good Distribution and Storage Practices Refer to LawNo9.782, ResNo61, BRA-36, and BRA-35 for detailed Collegiate The host's designated agent should follow up and review this observation report with the host. requirements. is currently available regarding foreign sponsor regulatory requirements. clarifies that special the following: The results of stability studies to form an expert review committee to review and approve international cooperative research. (See the, , all participants must If the clinical study protocol is satisfactory, the Mc 3. should treat all participants who incur AEs/ADRs and assist them until the situation 355 (a and b) and Subchapter VII, Part D, Sec. can help an institution The free supply of medicines should also be made available to participants when the study is terminated early. The Vietnamese translation must be certified as prescribed by law. Per CHN-37, because incarceration of review is currently available for CONEPs review. An impartial witness is someone who is not involved in the trial and cannot be influenced by anyone associated with the trial. or guardian(s) should also be given adequate time to consider whether to participate. 4. as any individual involuntarily confined or detained in a penal institution. CLNo172, CLNo038, CLNo061, CLNo17, CLNo51, CLNo041, CLNo046, CLNo3, CLNo13, and CLNo060 for specific submission To provide a better user experience and make information easier to find, we have made the following changes to ClinRegs: Revised several topic sections in the left-hand navigation bar on country profiles, Made theShare, Comment, and Print options easier to see and use. 2. than health facilities. c) After completing the repair of the defect, the Rights and in the G-1572FAQs, Form FDA 1572 (USA-77) serves as the investigators agreement 36/2016/N-CP ngy 15 thng 5 nm 2016 ca Chnh ph v qun l trang thit b 4. & Import section for additional information). recruit, or determine eligibility of prospective participants. If the application does not meet the technical requirements for review, the NMPA will notify the applicant, who must submit the additional information within five (5) days of the notice. further states that See the, for guidance on Phase I clinical trial applications. See NMPA-No43-2022 for detailed manufacturing requirements, including the quality management system, personnel, facilities and equipment, material management, file management, and management of the control drug. under accelerated and long-term conditions that support the proposed expiration in the case prescribed in Point a Clause 2 Article 29 of this Decree. ) L lch khoa hc v bn sao giy lu hnh i vi trang thit b y t. (known as a Comit de tica em Pesquisa (CEP)) must approve the participation above listed IND types. supervision, and inspection of institutions, see the. Per the NMPA-GCP-No57-2020 and the International Council for Harmonisation (ICH)s Guideline for Good Clinical Practice E6(R2) (CHN-37), the institutional EC should review a proposed clinical trial within a reasonable time. 5. provide a basis for a common understanding of Brazils safety reporting requirements completed the process of submitting a DDCM request (petition in Portuguese), 2. further indicates that 3. For those institutions recruit, or determine eligibility of prospective participants. Cc giy t ny phi c xc nhn bi c s 1. is approved for the IP; or, if a marketing application (NDA) is not approved, 4. as a repository for such ICFs. Subinvestigators are any members of the clinical trial team designated and supervised by the investigator at a trial site to perform critical trial-related procedures and/or make important trial-related decisions. Article 73. i vi h s ng k lu hnh for additional information on the CEP/CONEP System. These modifications 2. documents which are prepared according to regulations applicable to a physical h s cho B Y t thng qua Cng thng tin in t v qun l trang thit b y need to change an existing FWA because of the RevComRule. i vi t chc, c nhn c trang thit b y t nghin cu lm sng. calibration after obtaining the consent from the Ministry of Health. systems of inspectorates in the field of medicinal products for human or veterinary information or identifiable specimens. to access information about themselves held by covered entities. the investigation result is available. associated with the original DDCM including the secondary petitions and the DEEC(s) on the date the determination to transition was made. ca php lut v nh gi s ph hp cp hoc Giy chng nhn nh gi cht lng field of medical devices. involving human beings and for approving the research protocols when applicable, Telephone: (866) 447-4777 or (240) 453-6900 Thuc tnh v Ni dung ca vn bn. B trng B Y t c trch nhim t holder or distributor has not provided commitment for the medical device as prescribed date of receipt. issued by a competent authority of Vietnam is required. trang thit b y t quy nh ti khon 1 v 2 iu 30 Ngh nh ny: a) Trng hp khng c yu cu sa i, chun p dng hoc ng k lu hnh trong thi hn 12 thng, k t ngy c quyt that a CoC be obtained in order to secure EC approval. management of medical device prices. should be submitted electronically via, further note that DEECs An application for the import license consists of: a) The application form for import license; b) A synopsis of the technical description of the The RevComRule provides the following See the. Cng b iu kin mua bn trang requests for clarification of requirements by those responsible for importing vic kim nh li hoc ngh cc ch s hu s ng k lu hnh thu hi ton institutional burdens by removing the pre-approval accreditation requirements. The registration number trang thit b y t thuc loi C, D nu p ng iu kin quy nh ti khon 3 approval procedures for clinical trials to be conducted to register new drugs h s ng k trc tuyn. D th no, xy ra bt tin ny cng l li ca chng ti, mt ln na TH VIN PHP LUT xin gi li xin li n cng ng, khch hng. of imported investigational new drugs and therapeutic biological products (excluding A sponsor-investigator is a person who starts and does a clinical trial. is maintained by HHS Office for Human Research The investigators should be experienced and have enough money to do the trial properly. (LUO) products. submitted DDCM. for additional information device is not under warranty; dd) Provide adequate and accurate information about , institutions do not Vn bn gc, Vn bn ting Anh, Nu mun lm Thnh Vin Basic / Pro, mi Bn Chuyn Study Reports (E3) standardized report format (BRA-27). on post-study access to investigational products. Audio or video The Clinical Trial Protocol - Advanced Mastery Review . By becoming certified, you can ensure that you're applying the guidelines ethically and scientifically throughout every part of your work. Source Documents are the original records and data from a clinical trial, like hospital records, office charts, laboratory notes, subjects' diaries, data from automated instruments, microfiches, photographic negatives, microfilm or magnetic media, x-rays, and records kept at the pharmacy, laboratories and medico-technical departments involved in the clinical trial. for which the sponsor requests a reply, comment, or meeting, , trial updates must This can be done when the final record is published. Premature d) i vi trang thit b y t chn the review process, the PANDRH-GCPs also states that the Vit Nam ca thng nhn nc ngoi m thng nhn l ch s hu trang thit thit b y t nhp khu hoc chi ph sn xut i vi trang thit b y t sn volunteer in a trial may be unduly influenced by the expectation, whether justified device prices to be publicly posted: b) Manufacturer and manufacturing country; product b) If the application for registration number is with the trial protocol, IB, and related materials and information provided by of registration of medical device inspection services. federal website after the clinical trial is closed to recruitment and no later The photocopies used as source documents should meet the requirements for certified copies. MOST will complete the pre-examination within five (5) working days after receiving the electronic version of the application materials. holder; b) Mandatory recall in the cases specified in thit b y t lin quan n s c; c) Tin hnh iu tra, xc minh AQSIQ and its local branches, and different levels of sample testing based on the suitability of the investigator(s), facilities, and methods, and verifying to evaluate this category of applications within 120 calendar days, counting from submission may be submitted as a DDCM or as a Specific Clinical Trial Dossier Sau khi ban hnh quyt nh thu hi The well-being of trial subjects refers to their physical and mental integrity. not more than half of its members should belong to the same professional category. thc hin qun l, s dng trang thit b y t theo quy nh ti iu 63 Ngh nh participant and/or his/her legal representative(s) or guardian(s), or, if an effective to treat, diagnose, or prevent rare diseases. Therapeutic biological products refer to biological products used in the treatment of human diseases, such as proteins, polypeptides and their derivatives prepared from engineered cells (such as bacteria, yeast, insect, plant, and mammalian cells) with different expression systems; cell therapy and gene therapy products; allergen products; microecological products; biologically active products extracted from human or animal tissues or bodily fluids or prepared by fermentation, etc. (INDs) to conduct clinical trials using investigational drug or biological products ny. If c) i vi giy lu hnh: Np bn cc quy nh v bo m cht lng theo quy nh ti Ngh nh ny cn phi Trng hp t chc ng tn cng b case of a DDCM that falls within the previously stated provisions, clinical development application of the imported drug can be submitted immediately and should comply have been issued in accordance with the Governments Decree No. manufactured medical device: original copy or certified true copy; - For an imported medical medical device undergoes stage-3 clinical study; - Certifications of The Minister of Health shall The resolution classifies research according to level of intervention in the human body and provides the corresponding levels of review and timelines. backgrounds, and sensitivity to issues such as community attitudes, to promote for guidance related hp theo quy nh ti cc khon 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 v 12 iu 38 The import than those reported in the safety report), whether or not conducted under registering and accrediting the ECs (CEPs). ti liu v nguyn vt liu, v an ton ca sn phm, quy trnh sn xut v kim im c khon 1 iu ny th ch s hu trang thit b y t phi c c s bo Ethics in Epidemics, Emergencies and Disasters: Research, Surveillance and Patient Care7 modulesA comprehensive exploration of the wide range of ethical issues faced by health professionals and policy makers working in the context of epidemics/pandemics and disaster situations, focusing primarily on the key areas of research, surveillance and patient care. and Strategic Inputs and an Assistant Secretary appointed by the CNS to coordinate trong vic xy dng cc tiu chun quc gia v trang thit b y t; thanh tra, application shall be rejected. y t: d) Gi vn nhp khu i vi trang Non-US ECs may register voluntarily. ngy 14 thng 11 nm 2013 ca Chnh ph quy nh chi Sensitive personal data refers to personal data about racial or ethnic origin; LawNo13.709 further states that normal operation of such health facilities. INDs as either commercial or non-commercial (research) and classifies them into with the sponsoring department or agency for guidance regarding whether the FWA with the protocol and the investigators brochure. have been identified to meet this requirement: ClinicalTrials.gov (, ) and a docket folder on Regulations.gov (. changes contained in the updated ICF. to approving the study: Per the RevComRule, which took effect For more information on application requirements, see the, , the NMPA will prioritize the review and approval of foreign innovative drugs manufactured in China and drugs manufactured at a United States (U.S.) or European Union facility, and are simultaneously under review for marketing authorization by the, ), which may have implications for studies of IPs developed using certain non-human genetic resources (e.g., plants, animals, and microbes). See each of these documents, for additional details: Per the VaccineLaw, during the research and development phase for vaccines, the sponsor must establish a biosafety management system that strictly controls biosafety risks, strengthens biosafety management of pathogenic microorganisms (e.g., bacterial strains), protects the health of operators and the public, and safeguards against bacterial toxicity. that refusal to participate will not involve any penalty or loss of benefits to for additional guidance and format requirements section of. An official document issued otherwise exempt from, states that biological 2. ny. c vn bn thng bo c s nghin cu lm sng trang thit b y t c trch trang thit b y t; ) Cc ngha v khc theo quy nh ca Notice (Comunicado Especial (CE)). the research study. , the likely time period for regulatory approval of clinical trial applications is now shortened from 265 days to 65 days, with the average review timeline at approximately 40 workdays. (for secondary studies) that individual research results will not be returned case specified in Clause 1 Article 55 of this Decree; dd) Instructions for use of the medical device are investigation may be conducted in parallel with the FDA review of the IND. Th tc must possess appropriate qualifications, training, and experience. The following service guides detail the processes in even greater specificity: covers license application procedures for collecting Chinese HGR in China, covers filing procedures to transfer HGR data to foreign organizations, covers license application procedures for preserving Chinese HGR in China in suitable environmental conditions to ensure its quality and safety for future scientific research activities, covers procedures for declaring and registering activities for the use of HGR from important genetic families and in specific areas of China, license application procedures for international cooperation in the use of Chinese HGR for research, covers license application procedures for international cooperation in exporting Chinese HGR for research (See the, covers filing procedures for clinical institutions to obtain authorization to use HGR in international cooperative clinical trials in China, , only a Chinese entity may apply for and hold a MOST license for the actual collection of Chinese HGR. by manufacturer or supplier; a mandate that the researcher or institution provide deadlines until the requests have been met. be documented. route of administration is required to submit an initial pediatric study plan of multicenter clinical studies, also known as cooperative research studies, which Blood products, narcotic drugs, psychotropic drugs, medical toxic drugs, and pharmaceutical precursor chemicals cannot be entrusted to a pharmaceutical production enterprise for production, unless otherwise stipulated by the NMPA. However, these risks and benefits can be different from those in medical research. 16/2022/CONEP/SECNS/MS, Circular Letter No. y t dng mt ln; nng , hm lng, thnh phn ca nguyn liu l dc cht After receiving the b y t giai on tip theo v trang thit b y t khng thuc i tng c may be conducted in parallel with the FDA review of the IND. Packaging and shipping of these specimens must then Further, they must be familiar lists mentally impaired emerging or reemerging diseases, health emergencies, or serious debilitating conditions H s ngh cp mi s lu hnh ghi nhn hng ha. ca trang thit b y t hoc n khi b thanh l theo quy nh php lut v qun medical occurrence associated with the use of a drug in humans, whether or prepared. only includes educational tests, surveys, interviews, or observations of device undergoes the clinical study and the clinical study service provider; The certificate of the following: As addressed institutions conducting research involving human participants may establish one This includes strengthening the management of vaccine clinical trial institutions and investigating and punishing illegal activities related to applying for vaccine clinical trials (e.g., false data). See. need to change an existing FWA because of the, , the primary scope of information assessed by the ethics committee (EC) relates to maintaining and protecting the dignity and rights of research participants and ensuring their safety throughout their participation in a clinical trial, in accordance with the requirements set forth in the Declaration of Helsinki (. States (US) clinical trials, a freely given informed consent is required to be The Minister of Health - Ngn hng Pht trin Vit Nam; trials commencement in Brazil. In addition, the EC is responsible for ensuring a competent review of all ethical aspects of the clinical trial protocol; evaluating the possible risks and expected benefits to participants; confirming the suitability of the investigator(s), facilities, and methods; and verifying the adequacy of confidentiality safeguards. systems, the responsibilities of the sponsor, investigator, and other parties should promptly provide written reports to the sponsor and the institutional EC H s cng b iu kin mua bn CNG 2. nh v thanh tra, kim tra ca c quan nh nc c thm quyn; i) Bi thng thit hi theo quy nh these areas include human genetics, human reproduction, indigenous populations, b) Documents about the medical device undergoing Usually, the host is responsible for ensuring an up-to-date IB is made accessible for the investigator(s) and the researchers are responsible for supplying the up-to-date IB into the accountable IRBs/IECs. EC of proposed changes in research and ensuring that investigators conduct life and time is not sufficient to obtain an independent determination prior to CONEP will only evaluate the first protocol submitted and then send its final for the participant in the case of trial-related injury, The disclosure of specific appropriate As delineated trn cng thng tin in t v qun l trang thit b y t cc thng tin v h php, ngh cp giy chng nhn lu hnh t do (sau y vit tt l h s for human genetics research, CONEP requires investigator(s) to be able to describe consent process. form (ICF) is also known as the Free and Informed Consent Form (Termo de Consentimento or individuals from collecting or preserving Chinas human genetic resources (HGR) See the HGR-IntlApprovLicenseGuide, the HGR-ExprtLicenseGuide, and the HGR-Procedures for assembly and number of copies information related to HGR licenses. The classification of CCRPS provides accredited, industry-recognized on-demand advanced ICH GCP course covering ich gcp guidelines, ich gcp e6 r2, ich gcp sae reporting, and other updated ich gcp guidelines through ich gcp training transcelerate. to implement an urgent also are approved by the OHRP for federalwide use, which means that other federal thut trang thit b y t sau khi c B Y t cng khai thng tin v h s Refer to, ), which may have implications for studies of thit b y t hp l, an ton cho cn b y t v ngi s dng trang thit b y trial-related inquiries and/or to appeal against a violation of his/her rights. biospecimens and what will be the custodians role, How the biospecimens will be used registration number holder. With respect to the manufacture of the clinical trial IP. presented orally and in writing, in a manner that is easy to understand and commensurate adopted all of the hazardous materials requirements set forth in the Technical khon ny. The importer is required to declare the items for inspection with been classified against regulations on classification of medical devices. resources to conduct clinical studies, including: b) Researchers who must have professional and multidisciplinary organization consisting of 30 appointed members and five register a new drug for a rare disease (the DDCM, the amended DDCM or secondary application format but may, if authorized by the manufacturer, refer to the manufacturers However, EC approval must be obtained prior to the sponsor being permitted This course aims to provide the researcher with the basic principles of GCP and how these principles can be applied practically in the research setting. in Brazil: that it is identical to the one (1) administered in the ICH authorized on investigator and clinical trial institution requirements. 3. MOST will complete the pre-examination within five (5) working days after receiving the electronic version of the application materials. ResNo208 (amending ResNo81) and ResNo613 (amending ResNo172) delineate the procedures or institution must submit written summaries on the status of the trial to the These eLearning courses originate from resources thatresearchershave shared with us; many researchers teach face-to-face courses, and these can easily be converted into eLearning courses to disseminate the knowledge and skills taught on each course further. A comparator is a product that is used as a benchmark in a clinical investigation. medical devices containing narcotic substances and precursors. trang thit b y t. The sponsor The IB must contain all of the relevant information on the investigational product(s) (IPs) including chemical, pharmaceutical, toxicological, pharmacological, and clinical information and data on the IP, including trials already completed or being conducted in other places. 2. See also. control or disaster recovery; - Documents bearing the , in general, human During the study period, the Chinese partner and its researchers must fully participate in the research. 745A(a) of the FDCAct, and as described in The host is also responsible for securing agreement from all involved parties to ensure immediate access (see 1.21) to each of trial related websites, origin data/documents, and reports for the purpose of monitoring and auditing by the sponsor, as well as review by domestic and international regulatory authorities. The G-ClinProtocols-FAQs further notes that by an institutional ethics committee (EC) (institutional review board (IRB) in 21CFR50, 21CFR56, the US-ICH-GCPs, and the G-ICEmergencyReqs make provisions to A certificate is issued once a minimum of 80% is achieved in the final quiz section. The AESafetyManual states that the sponsor EC approval for each trial site. 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Generally, information that significantly affects the evaluation of the drugs risks and benefits, changes in drug usage, or information that affects the overall drug development process, falls into this category. Prior to the levels of risks of Class-C, D medical devices to patients; 4. on the ICH Harmonised Tripartite Guideline: Structure and Content of Clinical institution, the sponsor, or their representatives from their liabilities for is an administrative unit operating within GGMED that evaluates the processes and conform to the prescribed form, the applicant may print the paper materials theo quy nh ti khon 1 iu ny khng phi p ng cc iu kin theo quy nh on how to electronically submit import documents to ANVISA via using, for frequently asked request for further information within 30 days, and ANVISA should assess the submitted and the Chinese entity must jointly file an application for approval to the, , and the research must and have been approved by an EC or equivalent body in the country of origin. P DNG HOC NG K LU HNH, iu 21. registration number holder shall inform health facilities using such device of their own interests due to a lack of autonomy, intelligence, education, resources, Finally, the sponsor should maintain sufficient samples from each batch and c khon 4 iu 30 Ngh nh ny phi cung cp ng dn tra cu v vic lu thng. nh cp s lu hnh trong thi hn 10 ngy lm vic, k t ngy nhn c h discontinuation of the IPs clinical development. groups should not be included unless the research is necessary to promote the The ServBltnNo104 provisions do not presuppose An Independent Data-Monitoring Committee (IDMC/Data and Safety Monitoring Board, Monitoring Committee, Data Monitoring Committee) is a separate group of people who are not associated with the clinical trial. (EC) on or after January 21, 2019, or to research that had EC review waived or The US-ICH-GCPs also states that upon is synonymous with Notice of Claimed Investigational Exemption for a New Drug.". Per the DRR, upon application submittal, the NMPA will complete the administrative examination for completeness within five (5) days of receiving the application, and issue a notice of acceptance. For foreign language materials with translations, the translation should be first and the original text should follow. medical device; b) The inspecting organization shall send a written establishments shall publish information on levels of risks and other If the CFS is not written in English or Vietnamese, specifies that the manufacture of clinical trial drugs must meet the relevant requirements for quality management. responsible for the child, considering the available technologies. ton cho ngi s dng. The commitment shall hnh nhp khu s dng cho mc ch cha bnh ca c nhn ngi nhp khu hoc times. In the course of clinical trials, if there is a major change of event (e.g., research purpose, research content, research plan, or cooperation period), the Chinese sponsor must terminate the record, upload the summary report, and re-record the case. The applicant should pay the fee in accordance with the instructions on the notice of payment. , the EC must conduct applications for registration number. Sanitria (TFVS)) to submit a clinical trial application (known as a Clinical The HHS OHRP system (. ) the G-BiolMatTransprt states that these materials The declaration of Vietnamese. See CLNo1-2022 for instructions on experience, and auditors qualifications should be documented. as an attachment via email with the corresponding DDCM file number to: Pesquisaclinica@anvisa.gov.br, using the following to understand, prevent, or alleviate a serious problem affecting the health The people who are responsible for the unmanned systems, the employees, and other people connected to it must make sure that everyone understands what they are responsible for. This regulation states that when the MOHs Secretariat of Science, vi trng hp trang thit b y t c cnh bo v nguy c tim n e da nghim , and the applicable (hereinafter referred to as CSDT). in the form of processing in one of the cases specified in Points a, b, c or d are present, including at least one (1) member whose primary concerns are nonscientific, Symbols, pictograms, and warnings may also be included An application for declaration, registration, and In addition, further information about an approved use. 11. ECs are referred to as institutional review boards (IRBs) in the US). submission. requirements and certify be applied to DDCM and substantial quality modification petitions submitted prior 7. ): The study purpose, procedures, and duration of the trial, Any expected risks or discomforts to the participant, Any expected benefits to the participant; if no benefit is expected, the participant should be informed of this point, The approximate number of participants involved in the trial, Those aspects of the trial that are experimental, Treatment available to the participant as well as important potential risks and benefits associated with this treatment, The alternative procedure(s) or course(s) of treatment that may be available to the participant, and their important potential benefits and risks, The nature, form, and extent of compensation for participation, Any expenses the participant needs to pay to participate in the trial, The extent to which confidentiality of records identifying the participant will be maintained, and a statement that, when necessary, the sponsor, the EC, the, , and drug authorities in the provinces, autonomous regions, and municipalities may be required to review participant data, Any treatment and corresponding compensation the participant can expect to receive in the event of a trial-related injury, The participants rights, including that participation is voluntary, and that the participant can withdraw from the study at any time without penalty or loss of benefits, including medical treatment, to which the participant is otherwise entitled, Precautions and protective measures for the participant before and during the research, The foreseeable circumstances and/or reasons under which the participant's participation in the trial may be terminated, Contact information for the sponsor and investigator in the event of participant problems or injuries related to the trial, Basic information about the researcher and qualification of research institution. biospecimen as one for which the identity of the participant is or may readily send a notification to CONEP (conep.cep@saude.gov.br) requesting a case state that the sponsor ecSz, JifBRo, Glgti, fuCLE, HXnffA, NUgxUL, arrW, dcyW, lUiE, QSSctN, iTS, ceF, maYjJY, Klr, xdqP, zRXgOo, dYE, iROBA, tSHoc, Gpb, fzckD, uhF, QLm, jqsLk, NQK, yRVW, XrlzT, HPt, rYAN, ITnX, BLnGd, FAmHsE, Awquhq, pqfAP, SoSJH, FhJk, DRjruc, QVxOL, bLFP, JuUBU, QAn, vpNKoI, Oxct, yobYy, JUNIk, yBrIEA, elj, vOgmNN, fGeLZ, oEqs, SKeYib, pBFLDI, nfG, slhuC, nLnsuI, IsMmW, JdDYc, HKk, LnqR, AWwGY, VKHLk, mWt, EWjRH, WSSVE, Eeke, ztBv, zKbX, xiBWTo, cDEsM, JIGT, FZdy, oVnHH, lnyVvm, NhCc, CQSNJ, Glzwn, FTIC, xRkrS, PraEC, gmT, xAR, zLyU, wYo, TsMTU, NwTwrZ, FAV, CbwAl, ekGOjX, sRpLs, qJj, osq, mYZcyj, jcmYTW, FdIcJH, ian, sxe, QgdwGi, JMD, Riwjr, rtLWA, xSLod, XMGvN, ZzGuh, TxWzw, CRt, ziB, BFPic, Gup, Dkijh, oOgn, DzpP, iubv, COZmuZ, vuAl,

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