Samples should be kept until all trial data has been investigated or as needed by applicable regulatory requirements, whichever time period is longer. 5.5 Trial Management, Data Handling, and Record Keeping i.e. The records identifying the subject will be kept confidential and won't be made publicly accessible, as long as it is allowed by regulations or laws. Mittlerweile blicken wir auf ber 18 Jahre Erfahrung und Erfolge in der klinischen Forschung zurck. A Cloud Digital Leader can articulate the capabilities of Google Cloud core products and services and how they benefit organizations. Data and Analytics - NoSQL Databases, Relational Databases, Big Data. (c) Providing the investigational product(s) only to subjects who are qualified for it and in the protocol given dose(s). All queries concerning the trial ought to be answered to the satisfaction of the topic or the subject's legally acceptable representative. This form has information about what will happen during the trial. You'll also be able to demonstrate that you're adhering to the highest ethical and scientific standards possible. Summary: Good clinical practice provides a framework of principles which aim to ensure the safety of research participants and the integrity and validity of data. The sponsor must designate qualified medical staff that are available to counsel trial related health questions or issues. That is the least acceptable standard to work in the clinical research industry. For those researchers that are collecting further information, supplemental CRFs must also be supplied that are intended to capture the extra data. This includes the minimal present data described in this principle. Our innovative and easy-to-use GCP certification courses make it simple. There are agreements within the branches and organizations, but there is no national or worldwide agreement made. The IRB/IEC may be asked by investigators, sponsors or regulatory authorities to provide its written procedures and membership lists. The investigator/institution should also immediately inform the IRB/IEC and supply the IRB/IEC with a detailed written explanation of the termination or suspension. If they are capable, the subject should sign and personally date the written informed consent form. The researcher should keep records that show that subjects were given the doses specified by the protocol and reconcile all investigational product(s) obtained from the host. The aim of this regulatory standard is to ensure that the well-being, right and safety of the human beings recruited for clinical trials are protected. The investigator should tell the subject's primary physician about the subject's participation in the trial if the subject has a primary physician and if the subject agrees to the primary physician being informed. The investigator can answer any questions the IRB/IEC has about the trial, but should not join in their discussions or vote. 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. Changes to supply data should be traceable, shouldn't obscure the original entrance, and should be clarified if required (e.g., through an audit trail).". If the trial is stopped early or suspended for any reason, the investigator/institution should immediately notify the trial sponsor, the host institution, and the IRB/IEC. This applies regardless of the particular study and your function. Quality Assurance is a system that helps to make sure that clinical trials are done correctly and that the data generated is reliable. In the instance of a worker sponsored trial, then the sponsor-investigator must find out if a booklet is available in the industrial maker. The Professional Cloud Certifications are valid for two years from the date of issue. You may not attempt the same exam while currently certified unless you are within the recertification eligibility period starting 60 days prior to your certification expiration date. The outcomes of monitoring activities must be recorded so we can confirm that people followed the observation program. Before starting any clinical investigations, the host (or the host and the investigator, if required by applicable regulations) must submit any necessary programs to the proper authorities for approval and/or consent to start the trial. Throughout the ICH GCP Guideline the term protocol refers to protocol and protocol amendments. Enter Certificate ID. The certificate must be a template and follow the requirements outlined in this document review checklist: Instructions for Preparing GCP Training Sample Certificates. The modifications state that patrons cannot abdicate this duty and have to be more involved in the supervision of the CROs. a) the full works of GCP and should be a proper 2 day or so course. The name, address, and phone number(s) of their host company's medical practitioner (or dentist when appropriate) for the study. Additionally, there should be a statement from the IRB/IEC that it is functioning in accordance with GCP and applicable regulations. The opinion of an Independent Ethics Committee (IEC) is the judgement and/or advice provided by the committee. And some of the info listed below can be included in other protocol documents, like an Investigator's Brochure. Methods and timing for assessing, recording, and assessing of efficiency parameters must be described. This certification is a formal recognition of an individual's knowledge and competence in their ability to carry out applicable guidelines under different circumstances. The regulatory authority(ies) must be notified of any required reports. Before starting a trial, we should weigh the foreseeable risks and inconveniences against the anticipated benefit for the individual trial subject and society. In emergency situations, when it is not possible to get permission from the person beforehand, we should try to get permission from their legally acceptable representative. (f) Protect the blinding, if some (for example, keep the data during data entry and processing system ). If the protocol says that we can't get consent from the person in the trial or their legal guardian, the IRB/IEC should check that the proposed protocol and/or other document(s) address ethical concerns and meet regulatory requirements for such trials (for example, in emergency situations). The investigator should report to the IRB/IEC if there are any changes to the protocol that could eliminate immediate hazards to the trial subjects, if there are any changes that would increase the risk to subjects or affect the conduct of the trial, all adverse drug reactions that are both serious and unexpected, or any new information that may adversely affect the safety of subjects or the conduct of the trial. This serves as proof that legal, scientific and ethical standards are being met. Its job is to make sure that the rights, safety and wellbeing of human subjects involved in a study are protected. Click Finding a Course for tips on searching for courses. Frequently Asked Questions. Beyond GCP certification being a minimum requirement for clinical research professionals, there are a few other reasons why you need GCP certification. All information related to clinical trials should be recorded, stored, and handled in a way that allows for accurate reporting, interpretation, and verification. The updated statements today represent FDA's well-established advice on the researcher's supervisory responsibilities. The ICH sets the standard that defines the guidelines for Good Clinical Practice (GCP). This group is an international body that sets the standard which becomes regulations for clinical trials involving human subjects. In today's clinical research industry, ICH GCP training is more important than ever because medical science is constantly changing and research processes are becoming more complex. b) at least 1 day covering investigator responsibilities and an understanding of all parts of GCP which he is not directly responsible for. GCP certification is a requirement for all clinical research professionals, but it's especially important for those working in drug companies, research centers, hospitals, etc. The IB also gives insight to help the clinical direction of their research subjects throughout the course of this clinical trial. Modifying sample certificates from the TransCelerate website is strictly prohibited. The host or investigator/institution should incorporate these within this trial master document. Get started on your Good Clinical Practice certification today! Use statistical analysis to identify trends in the data, like the consistency and range of information within and across websites. This can be done when the final record is published. How are Global Health Network Training Courses produced? A trial should be conducted following the protocol that has received approval from an institutional review board (IRB) or independent ethics committee (IEC). Here are some ICH GCP training free online guidelines. The sponsor may also want to include a statement asking the investigator/recipients to keep the information in the IB private. It is recommended that employees in pharmaceutical and biotech companies are GCP certified. This includes both written and electronic changes. The IRB/IEC should make sure that the written informed consent form and any other written information given to subjects includes details about how much subjects will be paid for participating in the trial, including how the payment will be divided up. When using electronic trial data management and/or remote electronic trial information programs, the host needs to: (a) Ensure and document that the electronic data processing procedure(s) adheres to the sponsor's established requirements for completeness, accuracy and reliability, and consistent intended performance (i.e. The new guidelines will require sponsors to get training and tools to establish risk management principles. 3. institutional review board/independent ethics committee (irb/iec) 4. investigator . Conducting initial and continuing review of trials. Any similarities with other substances should be noted. ICH stands for the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Administration - Management, Monitoring, Authorization, Security The IRB/IEC should make decisions at announced meetings when at least a quorum of people are present, as stipulated in its written operating procedures. If you are a physician actively involved in a clinical trial, you must always provide evidence of having completed a basic GCP course (8 h) for physicians. The IRB/IEC should have a reasonable number of members who collectively have the qualifications and experience to review and evaluate the science, medical aspects, and ethics of the proposed trial. The tracks need to make sure that the trial will be done right by doing the following things: (a) Checking that the investigator has enough qualifications and tools to do the job. The timing and methods for assessing, recording, and assessing safety parameters must also be described. Google Cloud technology is ever-evolving. The host should notify all parties that are involved (e.g. The reason for the changes is because the former version was not well received. If an observation or audit reveals that an investigator or institution has been noncompliant for a long period of time, the host must terminate their involvement in the trial. by conducting clinical trials, attending . A description of the "stopping rules" or "discontinuation criteria" for different topics, elements of trial and complete trial. 1 Validity; scope; form. To advance in your career, you need to ensure you get the best training in clinical investigations from experts with years of industry experience with extensive knowledge and understanding of the ICH GCP guidelines. No subjects should be admitted to a trial until the IRB/IEC has approved it in writing. GCP is an international standard that ensures that ethical and scientific qualities are maintained in the designing, recording and reporting of clinical trials involving human subjects. The sponsor must submit security upgrades and periodic reports to the regulatory authority. How do I retake a quiz? About these Courses. You must recertify in order to maintain your certification status and certificate number (i.e., Series ID). They should be used in accordance with the approved protocol. The investigator must follow the rules for getting and documenting informed consent. The host must have agreements in writing with all the investigators/institutions and other parties involved in the clinical trial. The statement should include the name of the product being studied, all of the active ingredients, what the product is expected to do, and why the study is being done. The subject or the subject's legally acceptable representative must sign a form authorizing this access. (d) The followup to subjects withdrawn from investigational product treatment/trial therapy. The investigator should have enough people to help with the study who know what they are doing and have access to good facilities throughout the duration of the study. >. The auditor(s) should document their findings and observations. Investigational Merchandise is a product with an active ingredient or placebo being tested in a clinical trial, such as a product that is being used in a different way than what is approved, or for an unapproved reason, in order to get more information about an approved use. If you are already certified, passing a beta exam counts as recertification and your two-year certification term restarts. (1) These General Conditions of Purchase (hereafter " GCP ") apply to all business relationships between us, Gebr. In hospitals, pharmaceutical companies and CROs, the agreement has been made that a GCP training certificate obtained is valid for 2 to 4 years. If a coordinating committee or investigator will be used in multicentre trials, the sponsor is responsible for their company and/or choice. Please note, some training providers include expiration dates on their certificates that are unrelated to this GCP Mutual Recognition Program and are typically at the request of . no previous written or electronic record of data), also to be regarded as source data. This searchable course list provides training providers' sample certificates for reference purposes only. 5. sponsor . A serious adverse event (SAE) or serious adverse drug reaction (Serious ADR) is any negative medical occurrence that, at any dose: - results in death, - is life-threatening, - requires a hospital stay or makes a current hospital stay longer, - causes significant disability or incapacity, or - is a congenital anomaly/birth defect. The Investigator department (part 4) has been suggested for improvements. Do you work in the clinical research industry or are you interested in working in the clinical research industry? There is a new definition for "identification of automatic systems" under the definition for sudden adverse drug response (1.60). The identification of any data to be recorded directly on the CRFs (i.e. However, it is not clear how this new definition relates to adverse medication reactions. (b) The type and timing of this information to be collected for withdrawn subjects. The statement should also explain how the product will be tested.7.3.4 Physical, Chemical, and Pharmaceutical Properties and Formulation. When a clinical trial (therapeutic or non-therapeutic) includes subjects who can only be registered in the trial with the permission of the subject's legally acceptable representative (e.g., minors, or individuals with severe dementia), the subject ought to be informed about the trial to the extent that they can understand it. >. There are a few other reasons why you need the this certification. The validity period depends on several variables, which we explain below. This is according to applicable regulatory requirements. The investigator should have enough time to do the study and finish it within the time that was agreed upon. In the event of changes in the law, the refresher may also be required at an earlier date. A short summary (preferably not exceeding two pages) ought to be granted, highlighting the substantial physical, chemical and pharmaceutical, pharmacological, toxicological, pharmacokinetic, metabolic, and clinical data available that's pertinent to this point of clinical development of the investigational item. The monitor, auditor, IRB/IEC, and regulatory authority will be allowed to look at the subject's medical records to make sure the clinical trial is being done correctly, without violating the subject's confidentiality. Test now with our free online training advisor within two minutes which GCP training meets your specific needs: Wir sind ein Auftragsforschungsinstitut, das im Jahr 2004 von Dr. Andreas Grund gegrndet wurde. The requirement may be that a BROK certificate must have been obtained (UMCS), that a WMO/GCP certificate (peripheral and STZ hospitals) must be obtained or that a BROK WMO/GCP Exam ( Umcs and some STZ hospitals). Any changes to the protocol need written approval from the IRB/IEC, except when it is necessary to protect the subjects or when the change is only logistical (like changing monitors or telephone numbers). Yes, you may participate in a beta exam regardless of your certification status. The sponsor must appoint independent individuals to run research. When a backup is utilized to replace a first record. From a legal point of view, it is an obligation to show that you are aware of GCP andapplicable lawsuch as the European legislation and the WMO. The main things that monitors do are: (a) Make sure that subjects' rights and wellbeing are protected. The person or people investigating should be qualified for the job by their education, training, and experience. If the sponsor finds something that could negatively affect the safety of subjects or change how the trial is done, they must tell all of the concerned investigators and associations immediately, as well as the regulatory authority. The protocol is a plan that was approved by the sponsor and regulatory authority, if required. 8. Any revised written informed consent form, and written advice, must get the IRB/IEC's approval before it can be used. The Subject Identification Code is a number that is given to each person in a study. Effective October 1, 2022 the Associate Cloud Engineer certification is valid for three years from the date of certification. The company has a legacy of first to market and award-winning solutions that have been used to build some of the world's most renowned . To review them more effectively combine any two cards together if they both pertain to something related in theme (examples: "Committee" & Implementation). The specifications of the German Medical Association in the curriculum for GCP training are taken into account in the training advisor. Where permitted by law enforcement, a basic product information booklet, package leaflet, or data sheet could be a suitable choice, as long as it includes comprehensive, current, and accurate information on all aspects of the investigational product that may be of significance to the investigator. The Declaration of Helsinki was responsive to the revelations of the Nuremberg trials conducted after World War II, and its drafters sought to ensure that human subjects involved in clinical research would, in future, have their rights, safety and Those who renew a professional certification can make a $55 USD donation to one of two charitable organizations. With our course, you can learn at your own pace and complete it in as little as 10 hours. GCP partners with producers, contractors, designers and engineers to achieve performance and sustainability goals. 5. These fixed regulations do not apply to non-physician members of an audit group. The monitor should check that the right information has been reported on the CRFs. GCP training describes the responsibilities of investigators, sponsors, monitors, and IRBs in the conduct of clinical trials. Data handling and record keeping must be done according to the protocol. If the outcomes of the trial have been published, the subject's identity will stay confidential. The IRB/IEC must write to the investigator/institution to let them know about: (a) Any decisions or opinions relating to the trial. Pharmaceutical and biotech companies, as well as contract research organizations recommend that their employees are certified. Safety of Human Subjects in Clinical Research, Reporting Responsibilities of the Investigators, Ethics of Research Involving Mentally Incapacitated, Ethics of Research Involving Pregnant Women and Fetuses, Trial Management Data Handling and Record Retention, Common Terminology Used In Clinical Research, Commonly Used Abbreviations and Terms in Clinical Research, E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1), FDA resource for E6 r2 addendum (also included in course), Division of Microbiology and Infectious DiseasesDecember 2015. WHO Library Cataloguing-in-Publication Data Handbook for good clinical research practice (GCP): Linkedin Resource of ICH GCP related jobs and roles. The investigator and sponsor must sign the protocol, or another contract, to agree on the arrangements. They should also have enough time to read the protocol and other information provided. If a person cannot read or if their legal representative cannot read, an impartial witness must be present for the entire discussion about informed consent. Do you want to work in the clinical research industry? The investigator should make sure that the information they report to the host is accurate, complete, legible, and timely. The name and signature of the individual (s) authorized to sign the protocol and any changes to the protocol for your host company. Investigational products should be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP) guidelines. Location:Anne-Conway-Str. The sponsor must appoint qualified individuals who are independent of their clinical trials/systems to run research. All researchers are given directions on how to follow the protocol, how to comply with a uniform set of criteria for evaluating clinical and laboratory findings, and on finishing the CRFs. Are you looking for a way to brush up on your GCP knowledge? This includes designing the protocol and CRFs and preparing investigations into assessing and preparing interim and final clinical trial reports. We also offer completely fresh content in Refresher courses for retraining and advanced learners. GCP training gives people the important information they need to know about clinical research. Section 5.2 of the Contract Research Organization (CRO) states that sponsors need to be more active in overseeing their CROs. The Good Clinical Practice Certification is designed to give the researcher a basic understanding of the regulations and requirements for research using investigational (not approved by FDA) drugs or devices. (b) Making sure that there are enough facilities and employees to safely and properly conduct the trial. When people do audits as part of quality assurance, they should think about the purpose of the audit. All relevant stakeholders in clinical research require the appropriate GCP knowledge. The investigator/institution must keep the trial documents as stated in Essential Documents for the Conduct of a Clinical Trial (see 8.) The Audit Trail allows documentation to be re-examined on occasions. 3. The person or their representative should be told about the trial as soon as possible and agree to continue with additional approval if needed. 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. The sponsor must get written approval from the IRB/IEC for any changes to the trial, including the protocol, informed consent form, or other written information given to subjects. Compliance with GCP assures patients and the public that the rights, safety and wellbeing of people taking part in studies are protected and that research data is reliable. and can take advantage of the Google Cloud certified digital toolkit. But what if, in the meantime the legislation is updated as in this case? It helps to make sure that the data from the trial is accurate and can be trusted, and that the people taking part in the trial are treated fairly and their rights are protected. This includes confirming information, conducting statistical analyses, and preparing reports. Immediate Access means that we can look at, study, and copy any records and reports that are important to evaluating a medical trial. The investigator or a person designated by the investigator/institution must describe to each subject how to use the investigational product(s) properly and check at times appropriate for the trial that each subject is following directions correctly. Informed consent should be obtained from every subject prior to clinical trial participation. Because the content of the course depends on your role in a clinical trial and your prior experience, different formats of GCP courses exist. For any of the above I would appreciate confirmation of the regulations or guidance which state . A multicentre trial is a clinical trial that is conducted according to a single protocol but at more than one site. 4.1 Investigator's Qualifications and Agreements. ICH GCP. If the investigational product is supplied by this sponsor-investigator, then they must offer the essential info to the trial staff. Its objective is to deliver the researchers and others involved with the trial using all the data to facilitate their comprehension of the rationale behind, and their compliance with, several important features of this protocol, like the dosage, dosage frequency/interval, techniques of management: and security monitoring processes. An outline of this type/design of trial must be performed (e.g. (b) Keep records of when the product is sent, received, used, and destroyed (see 8). The investigator should ensure that the investigational product(s) are used only in compliance with the accepted protocol. identification ). Any person or organization (like national and international regulatory authorities, sponsor's monitors and auditors) that has direct access should take all reasonable measures to keep subjects' identities and sponsor's proprietary information confidential. The host's written SOPs must be followed in addition to the processes given by the host for tracking a particular trial. The form must be dated. They will also tell them who to talk to if they have any questions or problems, and how long the study will last. The medical care given to subjects and the medical decisions made on their behalf should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist. They should also meet all other qualifications that are required by the rules. During and after a subject's participation in a trial, the investigator/institution should make sure that the subject has access to adequate medical care for any adverse events, laboratory values, or intercurrent illnesses related to the trial. Failing a beta exam does not count toward the total allowable attempts on the final exam (4 attempts). These agreements can be in this protocol or in another arrangement. Ideally this can be proven with the aid of a training certificate. for deficient product remember, recover after trial completion( expired merchandise recover ). The investigator is the leader of the group and might be known as the researcher. The subject or the subject's legally acceptable representative should be informed as soon as possible if new information becomes available that may affect the subject's willingness to continue participating in the trial. 9. At GCP Central we make this a lot easier for you: we also train our students after obtaining their GCP certificate in legislative updates. Here you can learn more about the ICH-GCP regulations. Do I need to pay for my certificate at the end of the course? When a clinical trial is completed or stopped, the sponsor needs to make sure that the clinical trial results are given to the regulatory agency. 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