Drug Evaluation Committee Receipt of questions regarding clinical trials or GCP at Clinical Trial 119

Clinical Trial 119 is a website where the Clinical Evaluation Committee of the Drug Evaluation Committee presents the views of the Pharmaceutical Manufacturers Association of Japan in response to questions from medical institutions, SMOs, CROs, and pharmaceutical companies regarding clinical trials (company-led drug trials (clinical trials and post-marketing clinical trials)) or GCP, with the aim of contributing to the promotion of smooth and appropriate implementation of clinical trials. The questions that can be accepted are those related to clinical trials of pharmaceuticals or GCP.
Questions that can be accepted are those related to clinical trials or GCP of pharmaceutical products.
Please note that questions that fall under any of the following categories will not be accepted.

Questions should be sent to the secretariat by e-mail (e-mail address : chiken119@jpma.or.jp ) with your name and affiliation, including background information if possible, and we will reply with our opinion within one month. Please note that we may not accept anonymous questions.

Questions and opinions that are widely useful for the implementation of clinical trials will be published on the Clinical Trial 119 website, with the affiliation and name of the questioner withheld. If you wish to use the questions and opinions in Clinical Trial 119 in other materials (Internet, printed matter, etc.), please do not change or summarize the entire text of the question or opinion, but clearly indicate the source of the question or opinion. For any other use, please contact the secretariat (e-mail address : chiken119@jpma.or.jp) in advance and obtain the consent of the Pharmaceutical Manufacturers Association of Japan (PMAJ).

Clinical Trial 119 Questions and Views (2.7MB)

The GCP Guidance is only an example of the operation of the GCP Ministerial Ordinance, and other operations than those described in the Guidance are possible as long as the protection of human rights of subjects, safety, scientific quality of the trial, and reliability of the results can be ensured. The views of Clinical Trial 119 are based on the GCP Guidance, so please refer to these views as examples of operations.

It is important for the sponsor and the site to have active discussions to deepen mutual understanding.
Clinical Trial 119 provides and discloses, through external activities, the concept of problem solving based on specific examples, taking into consideration the protection of subjects' human rights, safety, scientific quality of the clinical trial, and reliability of the results.

Conference on CRC and Clinical Trials, 2022 "Consideration of questions and issues related to clinical trials received by Clinical Trial 119" (1.2MB)

Conference on CRC and Clinical Trials, 2021 "Reading Recent Trends from Questions Received on Clinical Trial 119! (1.6MB)

Please refer to the following links for reports and recommendations for improvement that were reviewed by the Drug Evaluation Committee and each subcommittee.

Drug Evaluation Committee Deliverables and Communications from the Committee

For inquiries regarding the implementation of clinical trials or changes to plans for pharmaceuticals and medical devices due to the impact of the new coronavirus infection, please refer to the link below. Please note that inquiries to Clinical Trial 119 regarding this matter will not be answered.

Clinical Trial Inquiry Desk, Review Planning Division, Review Management Department, Pharmaceuticals and Medical Devices Agency (PMDA)

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• Q 2024-37 Availability of data on cases of withdrawn consent for clinical trials
• Q 2024-23 Electromagnetic records using the clinical trial cloud system
• Q 2023-65 Investigator Signature on the List of Laboratory Reference Values in the Hospital
• Q 2023-63 Scope of non-expert members of a clinical trial review committee (Part 6)
• Q 2023-53 Revision of SOPs for the Use of eConsent
• Q 2023-51 Administration of Investigational Drugs at Affiliated Clinics
• Q 2023-49 Transcription from Source Documents to EDC
• Q 2023-36 Handling of Personal Information when Using ePRO
• Q 2023-33 Preparation of Monitoring Reports
• Q 2023-22 Obtaining Consent for Handling Personal Information of IRB Members
• Q 2023-14 IRB Rotational Deliberations
• Q 2023-06 Scope of ALCOA
• Q 2022-57 Sponsor's Opinion on Safety Information in Double-Blind Trials
• Q 2022-56 Are Tumor Specimens and Blood Samples Collected Included in Medical Information?
• Q 2022-55 Dispensing, auditing, and preparation services other than by clinical trial management assistants
• Q 2022-48 Necessity of SAE reporting at the time of hospitalization at the subject's request
• Q 2022-47 Clinical trial-specific handling of serious adverse events
• Q 2022-34 Documents explaining compensation for adverse health effects on subjects
• Q 2022-27 Web-based holding of clinical trial review committee meetings
• Q 2022-16 Use of residual specimens in clinical trials for future research
• Q 2022-13 Provision of patient information to sponsor prior to obtaining consent
• Q 2022-12 Handling of SAE Reporting for Admission for Scheduled Surgery (Part 4)
• Q 2021-71 Attribution of ePRO data
• Q 2021-70 Form 2 Custodian of Original List of Investigators and Collaborators
• Q 2021-59 Wash-out prior to obtaining consent
• Q 2021-44 Substitution for Consent Document by Person Equivalent to Alternate Consentor
• Q 2021-40 Necessity of Investigational Review Committee Review of Changes to Clinical Trial Protocol after Completion of Clinical Trial
• Q 2021-37 Review by a Clinical Trial Review Committee for deletion of a subinvestigator
• Q 2021-31 Obtaining consent on or after April 1, 2022
• Q 2021-26 Eligibility of investigational review committee members (Part 3)
• Q 2021-20 Transfer of investigational sites due to relocation of subjects
• Q 2021-16 Location of investigational drug control file
• Q 2021-07 Outside Members - Scope of "Persons with No Interest in the Conducting Medical Institution" (Part 8)
• Q 2021-02 Serious adverse events occurring during the screening period
• Q 2021-01 Provision of Clinical Trial Information to Patients Prior to Clinical Trial Agreement (Part 2)
• Q 2020-52 Contracting Procedures for Clinical Trials for which a National Clinical Research Manager is Appointed
• Q 2020-51 Procedures when changing SMOs
• Q 2020-48 Management Records of Investigational Drugs Used from the Performing Institution's Inventory
• Q 2020-43 Requests to an In-Country Clinical Trial Manager to Act on Behalf of the Investigator
• Q 2020-42 Documentation of the Consent Process in the Medical Record
• Q 2020-36 Inclusion in Source Documents of Medical Judgment by CRC Using Oral and Written Documents
• Q 2020-35 Record of withdrawal of consent for participation in a clinical trial
• Q 2020-33 Documentation of decisions on unknown/known adverse reactions in trials that have transitioned from clinical trials to post-marketing clinical trials
• Q 2020-30 Establishment of unblinded collaborators
• Q 2020-26 Temperature control records for investigational drugs
• Q 2020-23 Obtaining consent through online medical care
• Q 2020-22 Web-based clinical trial review committee meetings
• Q 2020-19 Management by the sponsor of subcontractors subcontracted from the CRO
• Q 2020-17 Methods for monitoring clinical trial-related documents
• Q 2020-16 Preservation of documents and records to be kept at the investigational site using a system provided by the sponsor, etc.
• Q 2020-14 Date discrepancy between "List of investigators and collaborators" and Delegation Log at the end of the work
• Q 2019-58 Obtaining consent for continued participation in a clinical trial by telephone and mail
• Q 2019-56 Obtaining consent from minor subjects who have been divorced
• Q 2019-48 How to keep contact records with subjects
• Q 2019-42 Clinical Trial Review Committee Review When the Director of the Establishing NPO is the Clinical Trial Coordinator
• Q 2019-41 Frequency of Clinical Trial Review Committee Meetings
• Q 2019-40 Identification of source documents - documents that are directly entered in the case report form and should be interpreted as source data (Part 2)
• Q 2019-38 Scope of the site management organization (SMO) to be included in the clinical trial notification (Part 2)
• Q 2019-36 Affiliations of Clinical Trial Review Committee Members
• Q 2019-31 Inspection of accuracy control, etc. of external laboratories
• Q 2019-29 Records regarding the location of documents and records pertaining to the clinical trial
• Q 2019-19 Necessity of inclusion in the investigational drug manager's delegation log
• Q 2019-16 Electromagnetic storage of documents subject to retention by the clinical trial review committee
• Q 2019-12 Changes to record retention periods during the conduct of a clinical trial
• Q 2019-06 Clinical trial-specific training for site personnel
• Q 2019-03 Concurrent membership on clinical trial review committee and conflict of interest committee
• Q 2019-02 Time to confirm investigator's opinion on safety information
• Q 2018-64 When additional investigational drug can be brought in at the time of change of sponsor
• Q 2018-62 Necessity of Review by the Investigational Review Committee at the Time of Transition from Clinical Trial to Post-Marketing Clinical Trial (Part 2)
• Q 2018-61 Change of Investigational New Drug Labeling with Change of Company Name and Location
• Q 2018-59 Change of sponsor due to transfer of new drug development rights
• Q 2018-54 Necessity of stating the amount of subject burden reduction expenses in the explanatory document
• Q 2018-52 Timing of obtaining re-consent (Part 4)
• Q 2018-49 Eligibility of members of a clinical trial review committee (Part 2)
• Q 2018-43 Clinical Trial Review Committee in the Absence of the Chair and Vice-Chair
• Q 2018-42 Issuer of Clinical Trial Review Results Notification Letter in the Absence of the Chairperson
• Q 2018-40 Documents or records pertaining to a clinical trial prepared in pencil (Part 2)
• Q 2018-37 Preservation of Relevant Documents and Response to Inspections When an External Clinical Trial Review Committee is Requested to Review the Clinical Trial
• Q 2018-36 Agreement by Investigator to Revised Clinical Trial Protocol
• Q 2018-34 Method of expedited review
• Q 2018-31 Request for provision of imaging data after submission of clinical trial end report
• Q 2018-29 Job titles of investigators and others to be included in the explanatory documents to subjects
• Q 2018-28 Necessity of subject consent when submitting additional specimens from stored tumor tissue
• Q 2018-27 Necessity of access to a copy of the signed consent form (office copy)
• Q 2018-18 Starting date for receipt of SAE report at the sponsor
• Q 2018-16 Informed consent to substitute consent by telephone
• Q 2018-12 Positioning of Addendum to Clinical Trial Protocol
• Q 2018-07 Adverse event evaluation of test results determined not to be clinically meaningful
• Q 2018-04 Re-administration of screening tests
• Q 2018-03 Review of the Clinical Trial Protocol and Other Documents in English Only
• Q 2017-83 Participation of members who are investigational drug administrators (in charge) in clinical trial review committee deliberations and voting (Part 2)
• Q 2017-81 Review of conflicts of interest in a clinical trial review committee
• Q 2017-79 Notification to the site regarding the end of the record retention period (Part 2)
• Q 2017-76 Definition of adverse event and causal relationship between adverse event and investigational drug
• Q 2017-73 Time to begin using the revised explanatory document
• Q 2017-71 Record of review of standard operating procedures
• Q 2017-66 Retention period for records of the conducting medical institution in post-marketing clinical trials
• Q 2017-65 Signatures of investigators and other investigators on training records
• Q 2017-61 Provision of adverse event information for subjects withdrawing consent
• Q 2017-60 Participation in clinical trials as subjects by employees of the implementing medical institution and others
• Q 2017-56 Selection of studies for audit
• Q 2017-55 Persons Submitting Review Materials to the Clinical Trial Review Committee
• Q 2017-52 Prior agreement and approval for deviation from the clinical trial protocol
• Q 2017-51 Delivery of original signed consent documents to subjects
• Q 2017-44 Access to records related to concomitant therapy
• Q 2017-38 Labeling when diverting marketed products in an expanded clinical trial
• Q 2017-37 Dates to be indicated by subjects, investigators, and others on consent documents
• Q 2017-35 Separate sheet of revised instructions to subjects
• Q 2017-34 Order of signatures on consent document
• Q 2017-33 Conduct of additional investigations after completion of the clinical trial
• Q 2017-32 Screening of medical records prior to obtaining consent by dispatched CRCs
• Q 2017-31 Participation of welfare recipients in clinical trials (Part 2)
• Q 2017-28 Obtaining Consent Outside the Performing Medical Center
• Q 2017-27 Handling of Signed Consent Forms Digitized by Scanner (Part 2)
• Q 2017-25 Handling when the substitute consentee is an employee of the implementing medical institution
• Q 2017-23 Definition of "clinical trial discontinuation/termination date"
• Q 2017-22 Clinical technologist's dual role as an investigational drug administration assistant
• Q 2017-20 Necessity of approval of an Appendix to the Clinical Trial Protocol by the Clinical Trial Review Committee
• Q 2017-18 Necessity of Review of Clinical Trial Participation Card and Other Documents by Clinical Trial Review Committee
• Q 2017-17 Matters to be included in the consent document
• Q 2017-15 What to do if continuing review is delayed
• Q 2017-11 Scope of investigational collaborators
• Q 2017-07 Recording Deviations from the Clinical Trial Protocol (Part 2)
• Q 2017-06 Scope of work for dispatched CRCs
• Q 2017-04 Inclusion of Results of Interim Analysis of the Study in the Revised Explanatory Document
• Q 2017-03 Scope of responsibility of monitors
• Q 2017-02 Record of review of source documents by investigators and others
• Q 2016-62 Retention period for records related to clinical trials that did not result in a contract
• Q 2016-59 Records assuring accuracy control, etc. in laboratories (Part 2)
• Q 2016-58 Substitute Consenters for Minor Subjects
• Q 2016-54 Timing of commencement of subject recruitment services
• Q 2016-53 Timing of obtaining re-consent (Part 3)
• Q 2016-48 Timing of obtaining re-consent (Part 2)
• Q 2016-41 Submission of notification documents regarding discontinuation of development
• Q 2016-36 Indication of the name of the target disease in the recruitment of test subjects
• Q 2016-35 Recording of deviations from the clinical trial protocol
• Q 2016-33 Timing of submission of clinical trial termination report (Part 3)
• Q 2016-32 Addition of required data items in case report forms
• Q 2016-31 Ordering of Clinical Trial-Related Tests by Physicians Other Than the Principal Investigator
• Q 2016-30 Resumption of Clinical Trial after Submission of End-of-Trial Report
• Q 2016-24 External committee members - Scope of "persons who have no interest in the implementing medical institution" (Part 7)
• Q 2016-22 Disclosure of clinical trial information after completion of a clinical trial
• Q 2016-21 How to Review Summary of Clinical Trial Review Committee Records
• Q 2016-20 Definition of remote monitoring
• Q 2016-18 Form for reporting follow-up information on serious adverse events to the Clinical Trial Review Committee
• Q 2016-17 Order of Preparation of Clinical Trial Review Committee Meeting Records and Agendas for Public Release
• Q 2016-16 Change in the Form of Establishment of the Clinical Trial Review Committee Establisher
• Q 2016-05 Retention of records of subject registration and investigational drug assignment
• Q 2016-02 Application of the Japanese ER/ES Guidelines to Clinical Trials
• Q 2015-47 Where to report supplemental information not directly related to SAE
• Q 2015-46 Temporary Leave of Absence for Clinical Research Collaborators During Clinical Trials
• Q 2015-41 Explanation to subjects regarding discontinuation of a clinical trial
• Q 2015-39 Continuation of Clinical Trials in Subjects Who Lose Capacity to Consent During a Clinical Trial
• Q 2015-37 Necessity of preservation of prescriptions
• Q 2015-36 Version control of explanation and consent documents
• Q 2015-33 Indication of simplified study name in subject recruitment
• Q 2015-29 Bulk filing of records to be kept by investigators and heads of investigational sites (Part 2)
• Q 2015-27 Presentation of medical information on past clinical trial participation in direct inspection of source documents
• Q 2015-26 Agenda title in minutes of clinical trial review committee meetings
• Q 2015-24 Changing the name of the sponsor of a clinical trial
• Q 2015-22 Change of Clinical Trial Review Committee during a clinical trial
• Q 2015-18 Prescreening of other clinical trials during a clinical trial
• Q 2015-15 Description of SAEs and number of deviations in the clinical trial status report
• Q 2015-12 Commissioning of Inspections Related to a Clinical Trial from an Investigational Organization (Part 2)
• Q 2015-08 Where to Store Required Documents
• Q 2015-06 Materials and information required for the preparation of explanatory documents
• Q 2015-04 Scope of documents related to procedures for recruitment of subjects
• Q 2015-02 Clinical Trial Contracts When a CRO is Involved (Part 2)
• Q 2014-58 External Members - Scope of "Persons with No Interest in the Conducting Medical Institution" (Part 6)
• Q 2014-55 Concurrent Appointment of Sponsor Medical Expert as a Member of a Clinical Trial Review Committee
• Q 2014-52 Handling of Assent in Mental Illness, etc.
• Q 2014-51 Provision of Safety Information from the Sponsor to the Clinical Trial Review Committee
• Q 2014-50 Provision of Investigational Drug Control Chart (Copy) to the Sponsor
• Q 2014-48 Anonymization of Subject Names in Materials Provided to the Sponsor
• Q 2014-46 Timing of obtaining re-consent
• Q 2014-45 Description of the person establishing the investigational review committee in the clinical trial notification
• Q 2014-43 Review by the Clinical Trial Review Committee of Your Own Hospital of a Recruitment Poster for Subjects in a Clinical Trial at Another Hospital
• Q 2014-42 Obtaining Consent and Wash-out of Previously Treated Drugs
• Q 2014-40 Clinical Trial Review Committee Meeting Records
• Q 2014-39 Temperature Storage of Investigational Drugs (Part 3)
• Q 2014-34 Clinical Trial Review Committee for a Single Clinical Trial at Multiple Medical Institutions
• Q 2014-33 Advertisement of Subject Recruitment in Patient Groups (Part 2)
• Q 2014-32 Reporting Serious Adverse Events in the Absence of the Investigator (Part 2)
• Q 2014-30 English Language Presentation of Source Documents
• Q 2014-29 Outsourcing of Clinical Trial Review Committee Review and In-House Clinical Trial Review Committee
• Q 2014-28 Designation of Temporary CRC as a Clinical Research Collaborator and Timing of Contract (Part 2)
• Q 2014-26 Necessity of storage of recovered clinical trial materials in double-blind studies
• Q 2014-23 Necessity of prescribing investigational drugs by investigators
• Q 2014-21 Necessity of preserving copies of safety information letters addressed to investigational review committees
• Q 2014-20 Revisions to subject information documents occurring during consent
• Q 2014-15 Preservation of test results and images prior to obtaining consent
• Q 2014-13 Clinical Trial Review Committee Review of Extension of Clinical Trial Period
• Q 2014-10 How to state reasons for revisions on source documents and case report forms
• Q 2014-09 Discharge of investigational drug in the absence of investigational drug manager
• Q 2014-06 Temperature storage of investigational drug (Part 2)
• Q 2014-02 Deviation from the study protocol to avoid immediate hazards
• Q 2014-01 Timing of submission of clinical trial termination report (Part 2)
• Q 2013-65 Record of Investigator's Review of Clinical Trial Agreement
• Q 2013-62 Emergency key code holders
• Q 2013-61 Whether a clinical trial status report is required for the survival study period
• Q 2013-60 Form of contract between the investigational new drug administrator and the CRO
• Q 2013-59 Start date for provision of investigational drug safety information
• Q 2013-56 Incorporation of more cases than contracted number of cases
• Q 2013-54 Handling of SAE report for hospitalization for planned surgery (Part 2)
• Q 2013-53 Conclusion of Clinical Trial Agreement with the Details Different from the Performing Institution Form
• Q 2013-51 Vacancy of a member of a clinical trial review committee
• Q 2013-50 Procedures for discontinuation of a clinical trial upon notification from the sponsor
• Q 2013-48 External Members in the Member List of the Clinical Trial Review Committee of a Contract Reviewer
• Q 2013-45 Scope of monitoring - Documents to be kept by the SMO
• Q 2013-43 Retention of Subjects' Diaries
• Q 2013-42 Loss of original SAE report form
• Q 2013-41 Temperature Control Methods for Investigational Drugs
• Q 2013-40 Clinical trial participation cards and information provided to other health care providers
• Q 2013-39 Anonymization of pharmacogenomics samples
• Q 2013-36 Identification as a "legal guardian
• Q 2013-35 Health Damage Compensation and Adverse Reaction Relief Systems in Post-Marketing Clinical Trials
• Q 2013-34 Change of the representative of the establishment in the Joint Clinical Trial Review Committee
• Q 2013-33 Concurrent Appointment of Principal Investigators, etc. in the Same Clinical Trial and at Multiple Medical Institutions
• Q 2013-32 Scope of substitute sponsor (Part 2)
• Q 2013-31 Handling of source documents whose original documents are thermal paper (Part 2)
• Q 2013-30 Scope of investigational drug management chart
• Q 2013-29 Designation of multiple investigational drug managers
• Q 2013-27 Recording method of oral consent and contents of explanatory documents
• Q 2013-22 Standard Operating Procedures for Medical Laboratories in a Network
• Q 2013-21 Review by the Clinical Trial Review Committee of additional/changed information on SAE
• Q 2013-20 Education and Training of Personnel at Contract Imaging Laboratories
• Q 2013-19 Clinical Trial Review Committee Review of Periodic Adverse Reaction Reports for Investigational Drugs Prior to the Conclusion of Clinical Trial Agreement
• Q 2013-17 Conflict of interest in a clinical trial review committee established by a non-profit organization
• Q 2013-16 Time to start work of a clinical trial sub-contractor
• Q 2013-15 Procedures for discontinuation of a clinical trial at the time of withdrawal of consent
• Q 2013-12 Record of agreement on target number of subjects
• Q 2013-11 Procedures to prevent alteration of sponsor's documents due to omission of clinical trial procedure document seal
• Q 2013-10 Attendance of Investigator at Clinical Trial Review Committee (Part 2)
• Q 2013-09 Scope of non-expert members of a clinical trial review committee (Part 5)
• Q 2013-08 Scope of Non-Expert Members of a Clinical Trial Review Committee (Part 4)
• Q 2013-07 Necessity of E-Mail Retention between Investigator and Sponsor
• Q 2013-06 How to Record Investigational New Drug Expiration Dates on the Investigational New Drug Control Chart
• Q 2013-05 Provision of Annexes/Branches of the Clinical Trial Protocol to the Investigational Organization
• Q 2013-04 Review by Clinical Trial Review Committee for additional/changed information on SAE
• Q 2013-03 Inclusion of pharmacogenomics analysis items in explanatory documents for subjects
• Q 2013-02 Agenda items to be included in the Clinical Trial Review Committee meeting record summary
• Q 2013-01 Capturing images for transition to electronic medical records
• Q 2012-54 Screening of medical records prior to clinical trial contracting
• Q 2012-53 Issuance of a notice of clinical trial review results upon review of investigators by a clinical trial review committee
• Q 2012-52 Signature requirement on case report form by investigational collaborator
• Q 2012-50 Materials required to be retained after expiration of GCP retention period
• Q 2012-49 Posting of Therapeutic Effects of Investigational Drugs in Advertisements for Subject Recruitment
• Q 2012-48 Data Entry into Case Report Forms by Administrative Personnel
• Q 2012-47 Necessity of e-mail review of subject referral request by Clinical Trial Review Committee
• Q 2012-46 Method of recording temperature control of investigational drug
• Q 2012-45 Revision of explanatory documents and re-consent that occur at the same time of change of investigators
• Q 2012-44 Difference between source documents and source data
• Q 2012-43 Retention of Signed Consent and Explanatory Documents
• Q 2012-42 Sequence of Approval for Selection of Investigator and Agreement on Clinical Trial Protocol
• Q 2012-41 Commissioning of Inspections Related to a Clinical Trial from a Performing Medical Institution
• Q 2012-38 Development of Procedures for Omission of Signatures and Stamps for Clinical Trial Procedures
• Q 2012-37 Investigational drug management using facilities of affiliated medical institutions, and processing and storage of biological specimens
• Q 2012-36 Notification of participation in a clinical trial to other attending physicians (other hospitals)
• Q 2012-35 Scope of Non-expert Members of Clinical Trial Review Committee (Part 3)
• Q 2012-34 Finalization of Clinical Trial Review Committee Minutes
• Q 2012-33 Drafting Date of Time for Continuing Review (Part 2)
• Q 2012-32 Provision of Reproductions and Copies of Source Documents to Sponsor
• Q 2012-31 Direct Inspection in Preparation for GCP Site Visit
• Q 2012-29 Digitization of Clinical Trial Review Committee Review Documents (Part 2)
• Q 2012-28 Use of Stamp Type Simple Stamp (Ink Penetrating Stamp) in Clinical Trial Procedural Documents
• Q 2012-27 Scope of subcontracting of contracted services by a CRO
• Q 2012-26 Handling of Investigational Medicinal Products by Persons Other Than Investigational Medicinal Product Managers and Clinical Trial Administrative Assistants
• Q 2012-24 Preservation of Appendix/Branch Supplement of Clinical Trial Protocol
• Q 2012-23 Items to be included in explanatory documents for subjects and their scope
• Q 2012-21 Packaging and labeling of control drugs, designated concomitant medications and basic therapeutic agents provided by the sponsor
• Q 2012-19 Handling of Comments from Absent Members at Clinical Trial Review Committee Meetings
• Q 2012-17 Disclosure of the name of the investigational site in the clinical trial disclosure information
• Q 2012-15 Use of drugs not approved in Japan as target drugs
• Q 2012-14 Inquiries from patients to sponsors regarding clinical trials
• Q 2012-13 Scope of expedited review
• Q 2012-12 Conducting tests using investigational drug
• Q 2012-11 Position of "Report" in a Clinical Trial Review Committee (Part 4)
• Q 2012-10 "Types of Clinical Trial Review Committees" to be described in the Explanatory Document for Subjects
• Q 2012-08 Pros and Cons of Designating the Chairman of the Board of Directors of a Medical Institution as a Member of a Clinical Trial Review Committee
• Q 2012-06 Scope of Deviation from Clinical Trial Protocol (Part 4)
• Q 2012-05 Indication of Expiration Date of Investigational Products
• Q 2012-04 Scope of "investigator-related committee members" (Part 4)
• Q 2012-01 Records to Assure Accuracy Control in Laboratories
• Q 2011-58 Holding a Clinical Trial Review Committee Meeting via Teleconference
• Q 2011-57 Termination of CRC dispatch contract during a clinical trial
• Q 2011-54 Handling of source documents whose originals are on thermal paper
• Q 2011-50 Handling of Signed Consent Forms Digitized by Scanner
• Q 2011-49 Agreement for entrustment of review by Clinical Trial Review Committee (Part 3)
• Q 2011-48 Preservation of Records, etc. Related to Contracted Testing by a Performing Medical Institution
• Q 2011-46 Identification of source documents - documents that are directly entered in case report forms and should be interpreted as source data
• Q 2011-45 Documents or records to be provided by the SMO for direct inspection
• Q 2011-44 Contracts for outsourced clinical laboratories (specimen analysis)
• Q 2011-43 Clinical trial protocol, appendix, need to provide list of monitors
• Q 2011-42 Recruitment of subjects via the Internet (Part 2)
• Q 2011-41 Recruitment of subjects via the Internet
• Q 2011-40 Necessity of reconfirmation after obtaining consent
• Q 2011-38 Notification of Discontinuation of Development or Clinical Trial after Closing of a Clinical Trial Site/Marketing Authorization
• Q 2011-37 Order of Request for Clinical Trial and Contract Review Agreement
• Q 2011-36 Retention of Consent Form (Copy) by the Performing Medical Institution
• Q 2011-35 Substitution of Minutes for Summary of Clinical Trial Review Committee Meetings for Publication
• Q 2011-34 Records to assure accuracy control, etc. in laboratories
• Q 2011-33 "Officers" in a clinical trial review committee established by an academic organization
• Q 2011-32 Confirmation of Intention to Continue a Clinical Trial after Revision of Explanatory Documents for Subjects (Part 4)
• Q 2011-31 Coverage of the uninsured concomitant therapy fee system (Interpretation of the notice on uninsured concomitant therapy fee)
• Q 2011-28 Inspections by Foreign Regulatory Authorities
• Q 2011-27 Overseas Regulations Applicable to Japanese Medical Institutions Conducting Multinational Clinical Trials
• Q 2011-23 Burden of Costs for Adverse Events (Interpretation of the Notice on Uninsured Combination Therapy Expenses) (Part 2)
• Q 2011-22 Necessity of establishment of a Clinical Trial Review Committee by the sponsor
• Q 2011-21 Preparation of source documents by CRC dispatched by SMO
• Q 2011-20 Recording and storing clinical trial-related information in electronic medical records shared with other medical institutions
• Q 2011-17 Attachments to the Common Line List for Individual Reporting
• Q 2011-15 Concurrent appointment of an advisor to the sponsor by the head of the implementing medical institution
• Q 2011-14 Agreement for contracted preparation of pathology specimens
• Q 2011-13 Scope of "investigator-related committee members" (Part 3)
• Q 2011-12 Clinical trial site Procedures for changing the name of a department
• Q 2011-11 Combination use of investigational drug and in-house preparation
• Q 2011-09 Electronic storage of safety information provided by the sponsor to the site
• Q 2011-07 Necessity of Review by Clinical Trial Review Committee at the Time of Transition from Clinical Trial to Post-Marketing Clinical Study
• Q 2011-05 Agreement for entrustment of review by Clinical Trial Review Committee (Part 3)
• Q 2011-03 Retention Period of Original Medical Records
• Q 2011-02 Blanket Appointment of Clinical Trial Collaborator
• Q 2010-58 Positioning of EDC Training Certificate
• Q 2010-57 External Retention of Documents or Records Related to Clinical Trials
• Q 2010-56 Permissibility of IRB participation by efficacy and safety evaluation committee members
• Q 2010-55 Contracting parties on the part of medical institutions in clinical trial agreements
• Q 2010-53 Necessity of re-consent due to change of subject cost reduction
• Q 2010-52 Necessity of a list of signatures and impressions in clinical trials using electronic CRFs
• Q 2010-51 Agreement for entrustment of review by a clinical trial review committee (Part 2)
• Q 2010-50 Change of Clinical Trial Procedure by Letter from the Sponsor
• Q 2010-49 Provision of Goods (to Subjects) in Lieu of Burden Reduction Payment
• Q 2010-46 Correction of Original Documents
• Q 2010-45 Correction of Errors in Consent Forms by Subjects
• Q 2010-44 Division of Roles between a Specialized Clinical Trial Review Committee and the Institutional Review Board (Part 2)
• Q 2010-42 SMO Services Provided by a Non-Profit Organization Establishing a Clinical Trial Review Committee
• Q 2010-41 Inclusion of Unidentified Persons in Clinical Trials
• Q 2010-39 Procedures for Requesting a Clinical Trial by a Clinical Trial Domestic Manager (Part 3)
• Q 2010-38 Collective Filing of Records to be Kept by Investigator and Head of Clinical Research Center
• Q 2010-37 Inspection of Medical Records When Two Affiliated Medical Institutions Conduct One Clinical Trial
• Q 2010-36 Necessity of Revision of Explanatory Documents for Subjects Due to Change in Location of Clinical Trial Review Committee, etc.
• Q 2010-35 Description of investigational drug control chart by CRC
• Q 2010-33 Confirmation of Intention to Continue a Clinical Trial with Revision of Explanatory Documents (Part 3)
• Q 2010-32 Concurrent Appointment of Sponsor's Medical Expert and Clinical Investigator
• Q 2010-30 Notification to the site of the end of the record retention period
• Q 2010-29 Establishment of a Self-Contained Clinical Trial Review Committee by a Clinical Research Organization Affiliated with a Legal Entity that Owns a Clinical Trial Review Committee
• Q 2010-28 Necessity of Retention of Laboratory Order Vouchers
• Q 2010-27 Change of investigators (Part 6)
• Q 2010-26 Necessity of review of investigator's curriculum vitae in English
• Q 2010-24 Confirmation of intent to continue a clinical trial following revision of explanatory document (Part 2)
• Q 2010-23 Entry of new subjects before the approval of the revised explanatory document by the Clinical Trial Review Committee
• Q 2010-22 Retention period of medical institution records in discontinuation of development, etc.
• Q 2010-21 Disclosure of information and the proceedings of the Clinical Trial Review Committee
• Q 2010-20 Participation of External Physician as a Clinical Research Assistant
• Q 2010-19 External Members - Scope of "Persons without Interests in the Host Institution" (Part 5)
• Q 2010-18 Division of Roles between Specialty Clinical Trials Review Committee and Institutional Clinical Trial Review Committee (Part 1)
• Q 2010-16 Continuing review at the end of a clinical trial (Part 1)
• Q 2010-14 Modification of "list of investigators and collaborators" prior to the conclusion of clinical trial agreement
• Q 2010-12 Position of "Report" in a Clinical Trial Review Committee (Part 3)
• Q 2010-10 Withdrawal of SAE report to the site
• Q 2010-09 Necessity of Investigational Review Committee Review of Use of Public Awareness Materials for Clinical Trials
• Q 2010-08 Support for Clinical Trials Conducted by Multiple SMOs
• Q 2010-07 Obtaining Consent for Potential Subjects with Potential Selection/Exclusion Criteria Conflicts
• Q 2010-06 Confirmation of Intention to Continue a Clinical Trial with Revision of Consent Declaration (Part 1)
• Q 2010-03 When a "Record Explaining Discrepancies between Source Documents and Case Report Forms" is Required
• Q 2010-02 When to Terminate Provision of Safety Information by the Sponsor (Part 2)
• Q 2010-01 Scope of Non-expert Members of Clinical Trial Review Committee (Part 2)
• Q 2009-59 Designation of an SMO representative as an investigational site record keeper
• Q 2009-58 Advertisement of recruitment of subjects in patient groups
• Q 2009-57 Consent to Eligibility Testing and Use in Other Trials
• Q 2009-56 Provision of Safety Information to Subjects Assigned to a Control
• Q 2009-55 Outside Committee Members - Scope of "Persons with No Interest in the Performing Institution" (Part 4)
• Q 2009-54 Response to Errata in Records
• Q 2009-51 Appeal to the Clinical Trial Review Committee
• Q 2009-49 Temporary Substitution of a Member of a Clinical Trial Review Committee
• Q 2009-47 Costs of conducting a clinical trial incurred after the trial period
• Q 2009-44 Request for Review by a Clinical Trial Review Committee of a General Incorporated Association, etc., of which the Head of the Performing Medical Institution is a Board Member
• Q 2009-43 Change of investigator (Part 5)
• Q 2009-42 Direct Inspection after Report of Clinical Trial Completion
• Q 2009-41 Change of investigators (Part 4)
• Q 2009-40 Participation of Investigational Drug Controller in Clinical Trial Review Committee Deliberations and Votes
• Q 2009-38 Whether or not the establisher of a clinical trial review committee may be a member of a clinical trial review committee
• Q 2009-37 Retention of Old Investigational New Drug Summaries at the Conducting Medical Institution
• Q 2009-36 Agreement on entrustment of review by a clinical trial review committee (Part 1)
• Q 2009-35 Procedures for Requesting a Clinical Trial by a Clinical Trial Domestic Manager (Part 2)
• Q 2009-33 Storage Media for Images to be Provided to the Clinical Trial Sponsor
• Q 2009-32 Version Control of Investigator Procedures (Part 2)
• Q 2009-31 Timing of Causality Determination for Adverse Events
• Q 2009-29 Items that must not be included in the Explanatory Document
• Q 2009-28 Necessity of Review by the Clinical Trial Review Committee due to Change of SMO
• Q 2009-27 Position of "Report" in a Clinical Trial Review Committee (Part 2)
• Q 2009-26 Procedures for Modification of Clinical Trial Agreement due to Change of CRO
• Q 2009-25 Disclosure of Clinical Trial Review Committee Member's Affiliation
• Q 2009-24 Preparation of Clinical Trial Review Committee Minutes by IRB Office Staff Who Also Serve as Clinical Research Collaborators (CRCs)
• Q 2009-23 Loss of original signed consent form
• Q 2009-22 Data entry in case report forms and preparation of documents or records related to clinical trials using water-based ink pens
• Q 2009-20 Inclusion of (basic therapeutic drug) product name on recruitment poster for subjects
• Q 2009-19 Scope of "committee members related to the investigator" (Part 3)
• Q 2009-18 Omissions and Errata in the Notification of Clinical Trial Review Results
• Q 2009-17 Use of External Clinical Trial Review Committee by Medical Institutions with Clinical Trial Review Committees
• Q 2009-16 Scope of "investigator-related committee members" (Part 2)
• Q 2009-15 Burden of Costs for Medication for Adverse Events (Interpretation of Notice Concerning Uninsured Combination Therapy Costs) (Part 1)
• Q 2009-13 Method of filing records when the clinical trial office also serves as the secretariat of the clinical trial review committee
• Q 2009-12 Position of "Report" in a Clinical Trial Review Committee (Part 1)
• Q 2009-10 Outside Members - Scope of "Persons with No Interests in the Conducting Medical Institution" (Part 3)
• Q 2009-09 Records at the time of SDV made by monitors
• Q 2009-08 Adjournment of Clinical Trial Review Committee (Part 2)
• Q 2009-07 Clinical Trial Review Committee Established by a Medical Corporation
• Q 2009-06 Form of Six-Month Accumulated Safety Information of Investigational Drug to be Provided to the Performing Medical Institution
• Q 2009-05 How to enter "Planned Quantity of Investigational Drugs to be Delivered per Site" in the Notification of Clinical Trial
• Q 2009-03 Communication of Safety Information (Study Report, Action Report, Withdrawal, etc.)
• Q 2009-02 Confirmation of Clinical Trial Completion Status by the Investigational Review Committee
• Q 2009-01 Transfer of investigational drug between sites
• Q 2008-54 Examples of non-therapeutic clinical trials
• Q 2008-53 Response to Publication of Procedures, etc. of Clinical Trial Review Committee
• Q 2008-52 Scope of information to be included in the summary of clinical trial review committee meeting records
• Q 2008-51 Places for posting advertisements for recruitment of test subjects
• Q 2008-50 Procedures for Requesting a Clinical Trial by a Clinical Trial Domestic Manager (Part 1)
• Q 2008-46 Handling of SAE Report for Admission for Examination
• Q 2008-45 Provision of Clinical Trial Information to Patients Prior to Clinical Trial Agreement
• Q 2008-44 Timing of Notification of Change of Clinical Trial Agreement for Change of SMO
• Q 2008-43 Use of Carriers by CROs for Delivery of Investigational Drugs
• Q 2008-42 Necessity of Investigator's Consideration for Periodic Reporting of Adverse Reactions, etc.
• Q 2008-40 Examples of "any change that may affect the clinical trial or increase the risk to subjects
• Q 2008-38 Scope of site management organization (SMO) to be included in clinical trial notification
  
• Q 2008-37 Procedures for selection of investigational review committee
• Q 2008-35 Curriculum Vitae of Clinical Investigators (Part 2)
• Q 2008-34 Conversion of Case Report Forms to EDC
• Q 2008-33 Additional Memorandum of Understanding (MOU)/Commitment for Protection of Subjects' Personal Information
• Q 2008-32 Necessity of Pharmacist Participation in Clinical Trial Review Committee
• Q 2008-31 Necessity of subject referral request letter review by Clinical Trial Review Committee
• Q 2008-30 Version control of the implementing medical institution's procedure manual (Part 1)
• Q 2008-29 Investigational drug managers affiliated with affiliated medical institutions
• Q 2008-28 Concurrent appointment of non-expert committee members and extra-institutional committee members (How to write the notification of clinical trial review results)
• Q 2008-26 Designation and contract timing of dispatched CRC as a clinical research collaborator (Part 2)
• Q 2008-25 Revocation of previously approved items by a clinical trial review committee
• Q 2008-24 Documents or records pertaining to a clinical trial prepared in pencil
• Q 2008-22 Extent to which records of deviations from the clinical trial protocol are required (Part 2)
• Q 2008-21 Scope of "investigator-related committee members" (Part 1)
• Q 2008-19 How to include safety information in the explanatory document
• Q 2008-18 Attendance of investigator at the Investigational Review Committee meeting
• Q 2008-17 Outside Committee Members - Scope of "Persons without Interests in the Conducting Medical Institution" (Part 2)
• Q 2008-14 Pharmacogenomics in Clinical Trials
• Q 2008-12 Starting date for continuing review period
• Q 2008-11 Scope of non-expert members of a clinical trial review committee (Part 1)
• Q 2008-10 Serious adverse event reporting in the absence of the investigator
• Q 2008-09 Implementation of duties of the head of the implementing medical institution by the President
• Q 2008-05 Review by the Investigational Review Committee of a Revised Explanatory Document for a Change in the Principal Investigator
• Q 2008-04 Review by a clinical trial review committee jointly established by multiple medical institutions - Change in the composition of the establishment of the committee
• Q 2008-03 Handling of SAE Reporting for Admission for Scheduled Surgery (Part 2)
• Q 2008-02 Publication of the Clinical Trial Review Committee Procedures, etc. via the SMO website
• Q 2007-37 Necessity of review by a clinical trial review committee for extension of the subject enrollment period
• Q 2007-36 Necessity of re-approval of protocols due to change of head of medical institution
• Q 2007-35 Necessity of stating in the clinical trial agreement that the sponsor will be present at the GCP site visit
• Q 2007-34 Re-admission of subjects who dropped out once during the observation period
• Q 2007-33 Procedures for Changing the Surname of a Clinical Research Collaborator
• Q 2007-32 Relationship between the duration of the clinical trial, the date of signing the agreement, and the time of delivery of the investigational drug
• Q 2007-31 Agreement for a single clinical trial conducted at two affiliated medical institutions (Part 2)
• Q 2007-28 Retention of original QOL questionnaires completed by subjects
• Q 2007-25 Electronic Clinical Trial Review Committee Review Documents
• Q 2007-24 Relationship between the opinion of the investigational review committee and the decision of the head of the investigational site
• Q 2007-23 Period during which re-consent must be obtained
• Q 2007-22 Timing of submission of clinical trial termination report
• Q 2007-21 Use of consent document prepared by medical institution
• Q 2007-20 Investigation of the effects of post-treatment after the completion of administration of the investigational drug
• Q 2007-19 Who to obtain re-consent when a surrogate consent is obtained
• Q 2007-18 Person to whom the consent document is signed on the date of signature
• Q 2007-16 Case Report Forms and Collection of Investigational Drugs Used in Clinical Trials after the End of the Contract Period
• Q 2007-14 Adjournment of Clinical Trial Review Committee (Part 1)
• Q 2007-13 Attendance of a member who is a physician is required for the establishment of a Clinical Trial Review Committee
• Q 2007-12 Qualification of Investigational Review Committee Members
• Q 2007-11 Scope of deviation from the protocol (Part 1)
• Q 2007-10 Attendance of both non-expert members of a clinical trial review committee and a non-expert member of a clinical trial review committee
• Q 2007-09 Review by a Clinical Trial Review Committee of a welfare recipient's participation in a clinical trial
• Q 2007-08 Agreement between two affiliated medical institutions to conduct a single clinical trial
• Q 2007-07 Participation of welfare recipients in a clinical trial
• Q 2007-06 Clinical Trial Agreement for a CRO to be Involved in a Clinical Trial from its Inception
• Q 2007-05 Necessity of Review of SOP by External Clinical Trial Review Committee
• Q 2007-04 Clinical Trial Review Committee Established by a Medical Corporation
• Q 2007-02 Obligation to report adverse drug reactions to a marketed concomitant drug (Part 2)
• Q 2007-01 Timing of appointment of investigational collaborator
• Q 2005-16 Participation of subjects in clinical trials during follow-up period in other clinical trials
• Q 2005-15 Provision of clinical trial protocol in electronic media, telecommunication of clinical laboratory data, etc.
• Q 2005-14 Transfer/change of investigators (Part 3)
• Q 2005-13 Handling of SAE report for hospitalization for scheduled surgery
• Q 2005-09 The concept of "majority" in the requirements for the formation of a Clinical Trial Review Committee
• Q 2005-08 Street distribution of advertisement for recruitment of test subjects
• Q 2005-07 Change of investigators (Part 2)
• Q 2005-06 Obligation to Report Adverse Reactions to Adjunctive Drugs (Part 1)
• Q 2005-04 Participation of potential investigational committee members as subjects in deliberations and voting
• Q 2005-03 Criteria for voting in a clinical trial review committee
• Q 2005-02 Handling of CVs of Clinical Research Collaborators
• Q 2005-01 Timing of appointment and contract of dispatched CRC as a clinical research collaborator (Part 1)
• Q 2004-18 Outside members - Scope of "persons with no vested interest in the site" (Part 1)
• Q 2004-14 Points to keep in mind when a single clinical trial is conducted at multiple medical institutions
• Q 2004-13 Requirements for an "impartial witness
• Q 2004-12 Whether or not the sponsor should interview subjects directly
• Q 2004-11 Scope of work of a physician appointed as a collaborator in a clinical trial
• Q 2004-10 External storage of medical records
• Q 2004-09 Scope of minor changes
• Q 2004-08 Composition of the Clinical Trial Review Committee - Number of External Members
• Q 2004-07 Contracting parties on the part of the sponsor and the clause on compensation for health hazards in the contract
• Q 2004-06 Collection of medical information from other medical institutions visited by the subject during the clinical trial
• Q 2004-05 Modification of Contracts upon Change of Head of a Medical Institution (Part 2)
• Q 2004-04 Modification of contract due to change of head of medical institution (Part 1)
• Q 2004-03 Appropriateness of nomination of medical school faculty members as external committee members
• Q 2004-02 How to cite GCP ordinances
• Q (9) Clinical trial protocol and record of nomination of monitors
• Q (8) Termination of provision of safety information by the sponsor (Part 1)
• Q (7) Response to the consolidation of medical institutions (6) Harmful effects after the contract term
• Q (6) Necessity of contract for follow-up of adverse events after the contract period
• Q (5) Costs of reducing the burden on subjects
• Q (4) Scope of substitute subjects
• Q (3) Method of stating the date consent was obtained on the case report form
• Q (2) Entry of foreign subjects
• Q (1) Change/replacement of investigator (Part 1)

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