Drug Evaluation Committee Clinical Trial 119: Search by Category

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Q 2024-37 Availability of data on cases of withdrawn consent for clinical trials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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