logging in or signing up Responsibilities of sponsor amolpharma Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 2233 Category: Science & Tech.. License: All Rights Reserved Like it (6) Dislike it (0) Added: February 10, 2009 This Presentation is Public Favorites: 4 Presentation Description Responsibilities of sponsor related to clinical research Comments Posting comment... By: sapna.d (9 month(s) ago) very nice presentation, can I please download this ppt? Saving..... Post Reply Close Saving..... Edit Comment Close By: vinitasharma (15 month(s) ago) i like it as its very authentic and informative Saving..... Post Reply Close Saving..... Edit Comment Close By: anuradha.prasad (26 month(s) ago) can we pls download this informative ppt? Saving..... Post Reply Close By: amolpharma (26 month(s) ago) No, you can not. But you can refer. Saving..... Edit Comment Close By: amolpharma (40 month(s) ago) It is very informative and presented well. Saving..... Post Reply Close By: amolpharma (26 month(s) ago) Thanks Saving..... Edit Comment Close Premium member Presentation Transcript Responsibilities of Sponsor : Amol Khedkar B.Pharm M.Tech(Biotech) +91-9763921244 email: amolkhedkar@gmail.com A Presentation on……… Responsibilities of Sponsor Sponsor : Sponsor A sponsor is an individual or a company or an institution that takes the responsibility for the initiation, management and/or financing of a clinical study. In case an investigator independently initiates ans takes full responsibility for trial. Clinical trial : Clinical trial The clinical trials conducted are broadly divided in two classes: For regulatory purpose: P’utical industry For academic Projects: Institution Sponsor’s Responsibilities : Sponsor’s Responsibilities Relationship between investigator, sponsor and CRO : Relationship between investigator, sponsor and CRO Sponsor Investigator Clinical Trial Monotors Conducts A Relationship between investigator, sponsor and CRO : Relationship between investigator, sponsor and CRO Sponsor CRO Investigator Clinical Trial Chooses Monitors Conducts B Relationship between investigator, sponsor and CRO : Relationship between investigator, sponsor and CRO Sponsor CRO Investigator Clinical Trial Hires chooses Monitors Conducts Monitors Selection of Investigator and Clinical Trial Site : Selection of Investigator and Clinical Trial Site The sponsor must assure itself of the investigator’s qualification and availability for the entire duration of the study The sponsor is responsible for selecting the investigator/ clinical trial site after ensuring the appropriateness and availability of the study site and facilities. Factor involved in Investigator selection : Factor involved in Investigator selection i. Reputation of the investigator in his/her field of expertise based on experience of conducting clinical trial as per GCP ii. Availability of infrastructure at the clinical trial site for conduct of the study e.g. equipment, trained personnel. iii. Availability of subject population for timely enrollment of the subjects in the trial0 Factor involved in Investigator selection… : Factor involved in Investigator selection… iv. Ease of accessibility of the trial site to the sponsor v. Ability of the Ethics Committee(EC)/ IRB to execute all its responsibilities. vi. Anticipated time required to initiate and complete the trial vii. Budgetary factors i.e. cost of the trial to the sponsor Preparation of clinical Trial Documents : Preparation of clinical Trial Documents The sponcer holds a key responsibilities of preparing all the clinical trial documents includes Investigator’s Brochure Protocol Case record form Informed consent document Subject Record Diary Agreement/Contract : Agreement/Contract The sponsor holds the responsibility to enter into a formal and legal agreement/contract with the Investigator /clinical trial site on the following terms: To conduct the study in compliance with GCP, the applicable regulatory requirement and as per the protocol. To comply with the procedure for data recording and reporting Agreement/Contract (ctnd….) : To permit monitoring, auditing and inspection Agreement/Contract (ctnd….) To retain the study related essential document the sponsor informs in writing that these documents are no longer needed. Standard Operating procedure(SOPs) : Standard Operating procedure(SOPs) The sponsor is responsible for establishing detailed Standard Operating Procedure for the conduct of the clinical trial. Allocation of Duties and responsibilities : Allocation of Duties and responsibilities To define and allocate all study related duties and responsibilities to the identified presons/department/organization. Study management, Data Handling and Record Keeping : Study management, Data Handling and Record Keeping Access to all study related sites, source data/document and report Data processing Statistical analysis Preparation of study report Study management, Data Handling and Record Keeping : Study management, Data Handling and Record Keeping Preparation and submission of material to the ethics committee, regulatory authorities and any other review bodies Reporting the ADRs, AEs Quality assurance and quality control systems. Compensation for Participation : Compensation for Participation The sponsor is responsible for making provision of compensation, travel and time spent for their participation in clinical research. All payments, reimbursements and medical services to be provided to research subjects should be approved by the EC/IRB Comfirmation of review by the Ethics Committee : Comfirmation of review by the Ethics Committee The sponsor is responsible for obtaining the documented approval/favorable opinion of the EC/IRB before the initiation of the study and the particulars about the members of the EC/IRB including their names and designations, form the investigator and/or the clinical trial site. Supply, Storage and handling of pharmaceutical products : Supply, Storage and handling of pharmaceutical products The sponsor is responsible for sypplying the investigational products, including comparator and placebo if applicable. The product should be manufactured in accordance with the principles of GMP and they should be suitably packaged and labelled. Supply, Storage and handling of pharmaceutical products…… : Supply, Storage and handling of pharmaceutical products…… It is responsibility of the sponsor to determine the acceptable storage, conditions, reconstitution procedure and devices for product infusions. The sponser is responsible for procuring and maintaining document related to adequate and safe receipt, handling, storage and dispencing of the product and return of unused product to the sponsor. Supply, Storage and handling of pharmaceutical products : Supply, Storage and handling of pharmaceutical products The sponsor is also responsible for maintaning sufficient samples form each batch and keeping the record of their analyses and COA. So that if necessary an independent laboratory may be able to recheck the same. Safety Information : Safety Information The sponsor is responsible for evaluation of the safety of the product on an ongoing basis. In case of findings, which could potentially affect the safety of the subjects, the sponsor should promptly notify all concerned and should take appropriate measures necessary to safegaurd the study subjects. Adverse Drug Reaction(ADR) Reporting : Adverse Drug Reaction(ADR) Reporting The sponsor holds the responsibility of providing ADR/AE reporting forms to the investigator/institution and reporting to all concerned of all serious and/or unexpected ADRs. Study Reports : Study Reports It is the Responsibility of the sponsor to ensure the preparation of a final clinical study report as per standards of the GCP guidline format and content of clinical study report . (ICH E3) Monitoring : Monitoring It is the sponsor responsibility to ensure appropriate conduct and monitoring of the study. The monitoring should be carried out by adequately trained monitors or CRO appointed by sponsor, to supervise an ongoing study. Audit : Audit As a part of the QA system, it is responsibility of the sponsor to preform an independent audit by appropriately trained and qualified audit personnel to ensure compliance with the protocol, SOPs, GCPs and applicable regulatory requirement. Role of a Foreign Sponsor : Role of a Foreign Sponsor If the sponsor is a foreign company, organization or perso, it shall appoint a local representaitve or CRO to fulfill the appropriate local responsibilities as governed by the national regualtions. Responsibilities of the Monitor Appointed by the Sponsor : Responsibilities of the Monitor Appointed by the Sponsor The monitor is the principal communication link between the sponsor and the investigator. The monitor should have adequate scientific qualification and practical clinical trial experience. Responsibilities of the Monitor Appointed by the Sponsor : Verification of investigator qualification, expertise and the resources to carry out the study. Availability of investigator throughout the study Adequte and continued availability of institutional facilities like laboratories, equipment, staff, storage space. Responsibilities of the Monitor Appointed by the Sponsor Responsibilities of the Monitor Appointed by the Sponsor (contd……) : Responsibilities of the Monitor Appointed by the Sponsor (contd……) Ensure that the investigational product are supplied only to eligible subjects at the specified dose and time and with proper instruction for handling. Ensure the documentation of the receipt, use, return and disposal of the product at the site. Responsibilities of the Monitor Appointed by the Sponsor Responsibilities of the Monitor Appointed by the Sponsor (contd……) : Responsibilities of the Monitor Appointed by the Sponsor (contd……) Ensure compliance of protocol and maintenance of essential documents by the investigator. Ensure appropriate training and further compliance to the protocol, SOPs and GCP guidelines by investigator and the study team. Responsibilities of the Monitor Appointed by the Sponsor Responsibilities of the Monitor Appointed by the Sponsor (contd……) : Responsibilities of the Monitor Appointed by the Sponsor (contd……) Ensuring that all CRFs are correctly filled out in accordance with original observations consistent with source document. Submitting a written report to the sponsor after each site visit and after all communication as precribed by the SOPs. Responsibilities of the Monitor Appointed by the Sponsor Multicentric Studies : Multicentric Studies In case of multicentric studies, it is responsibility of the sponsor to make special administrative arrangements, appointing a coordinationg committee/coordinator. The sponsor should obtain written aeeptance of the protocol and its annexes from each of the investigator and institution involved Premature Termination or Suspension of a Study : Premature Termination or Suspension of a Study In case the sponsor chooses to or is required to terminate prematurely or suspend the study, then the sponsor should notify the investigator, institution, the ethics committee and the regulatory authorities. The notification should document the reason for the termination by the sponsor or by the investigator/institution. THANK YOU : THANK YOU You do not have the permission to view this presentation. In order to view it, please contact the author of the presentation.
Responsibilities of sponsor amolpharma Download Post to : URL : Related Presentations : Share Add to Flag Embed Email Send to Blogs and Networks Add to Channel Uploaded from authorPOINT lite Insert YouTube videos in PowerPont slides with aS Desktop Copy embed code: (To copy code, click on the text box) Embed: URL: Thumbnail: WordPress Embed Customize Embed The presentation is successfully added In Your Favorites. Views: 2233 Category: Science & Tech.. License: All Rights Reserved Like it (6) Dislike it (0) Added: February 10, 2009 This Presentation is Public Favorites: 4 Presentation Description Responsibilities of sponsor related to clinical research Comments Posting comment... By: sapna.d (9 month(s) ago) very nice presentation, can I please download this ppt? Saving..... Post Reply Close Saving..... Edit Comment Close By: vinitasharma (15 month(s) ago) i like it as its very authentic and informative Saving..... Post Reply Close Saving..... Edit Comment Close By: anuradha.prasad (26 month(s) ago) can we pls download this informative ppt? Saving..... Post Reply Close By: amolpharma (26 month(s) ago) No, you can not. But you can refer. Saving..... Edit Comment Close By: amolpharma (40 month(s) ago) It is very informative and presented well. Saving..... Post Reply Close By: amolpharma (26 month(s) ago) Thanks Saving..... Edit Comment Close Premium member Presentation Transcript Responsibilities of Sponsor : Amol Khedkar B.Pharm M.Tech(Biotech) +91-9763921244 email: amolkhedkar@gmail.com A Presentation on……… Responsibilities of Sponsor Sponsor : Sponsor A sponsor is an individual or a company or an institution that takes the responsibility for the initiation, management and/or financing of a clinical study. In case an investigator independently initiates ans takes full responsibility for trial. Clinical trial : Clinical trial The clinical trials conducted are broadly divided in two classes: For regulatory purpose: P’utical industry For academic Projects: Institution Sponsor’s Responsibilities : Sponsor’s Responsibilities Relationship between investigator, sponsor and CRO : Relationship between investigator, sponsor and CRO Sponsor Investigator Clinical Trial Monotors Conducts A Relationship between investigator, sponsor and CRO : Relationship between investigator, sponsor and CRO Sponsor CRO Investigator Clinical Trial Chooses Monitors Conducts B Relationship between investigator, sponsor and CRO : Relationship between investigator, sponsor and CRO Sponsor CRO Investigator Clinical Trial Hires chooses Monitors Conducts Monitors Selection of Investigator and Clinical Trial Site : Selection of Investigator and Clinical Trial Site The sponsor must assure itself of the investigator’s qualification and availability for the entire duration of the study The sponsor is responsible for selecting the investigator/ clinical trial site after ensuring the appropriateness and availability of the study site and facilities. Factor involved in Investigator selection : Factor involved in Investigator selection i. Reputation of the investigator in his/her field of expertise based on experience of conducting clinical trial as per GCP ii. Availability of infrastructure at the clinical trial site for conduct of the study e.g. equipment, trained personnel. iii. Availability of subject population for timely enrollment of the subjects in the trial0 Factor involved in Investigator selection… : Factor involved in Investigator selection… iv. Ease of accessibility of the trial site to the sponsor v. Ability of the Ethics Committee(EC)/ IRB to execute all its responsibilities. vi. Anticipated time required to initiate and complete the trial vii. Budgetary factors i.e. cost of the trial to the sponsor Preparation of clinical Trial Documents : Preparation of clinical Trial Documents The sponcer holds a key responsibilities of preparing all the clinical trial documents includes Investigator’s Brochure Protocol Case record form Informed consent document Subject Record Diary Agreement/Contract : Agreement/Contract The sponsor holds the responsibility to enter into a formal and legal agreement/contract with the Investigator /clinical trial site on the following terms: To conduct the study in compliance with GCP, the applicable regulatory requirement and as per the protocol. To comply with the procedure for data recording and reporting Agreement/Contract (ctnd….) : To permit monitoring, auditing and inspection Agreement/Contract (ctnd….) To retain the study related essential document the sponsor informs in writing that these documents are no longer needed. Standard Operating procedure(SOPs) : Standard Operating procedure(SOPs) The sponsor is responsible for establishing detailed Standard Operating Procedure for the conduct of the clinical trial. Allocation of Duties and responsibilities : Allocation of Duties and responsibilities To define and allocate all study related duties and responsibilities to the identified presons/department/organization. Study management, Data Handling and Record Keeping : Study management, Data Handling and Record Keeping Access to all study related sites, source data/document and report Data processing Statistical analysis Preparation of study report Study management, Data Handling and Record Keeping : Study management, Data Handling and Record Keeping Preparation and submission of material to the ethics committee, regulatory authorities and any other review bodies Reporting the ADRs, AEs Quality assurance and quality control systems. Compensation for Participation : Compensation for Participation The sponsor is responsible for making provision of compensation, travel and time spent for their participation in clinical research. All payments, reimbursements and medical services to be provided to research subjects should be approved by the EC/IRB Comfirmation of review by the Ethics Committee : Comfirmation of review by the Ethics Committee The sponsor is responsible for obtaining the documented approval/favorable opinion of the EC/IRB before the initiation of the study and the particulars about the members of the EC/IRB including their names and designations, form the investigator and/or the clinical trial site. Supply, Storage and handling of pharmaceutical products : Supply, Storage and handling of pharmaceutical products The sponsor is responsible for sypplying the investigational products, including comparator and placebo if applicable. The product should be manufactured in accordance with the principles of GMP and they should be suitably packaged and labelled. Supply, Storage and handling of pharmaceutical products…… : Supply, Storage and handling of pharmaceutical products…… It is responsibility of the sponsor to determine the acceptable storage, conditions, reconstitution procedure and devices for product infusions. The sponser is responsible for procuring and maintaining document related to adequate and safe receipt, handling, storage and dispencing of the product and return of unused product to the sponsor. Supply, Storage and handling of pharmaceutical products : Supply, Storage and handling of pharmaceutical products The sponsor is also responsible for maintaning sufficient samples form each batch and keeping the record of their analyses and COA. So that if necessary an independent laboratory may be able to recheck the same. Safety Information : Safety Information The sponsor is responsible for evaluation of the safety of the product on an ongoing basis. In case of findings, which could potentially affect the safety of the subjects, the sponsor should promptly notify all concerned and should take appropriate measures necessary to safegaurd the study subjects. Adverse Drug Reaction(ADR) Reporting : Adverse Drug Reaction(ADR) Reporting The sponsor holds the responsibility of providing ADR/AE reporting forms to the investigator/institution and reporting to all concerned of all serious and/or unexpected ADRs. Study Reports : Study Reports It is the Responsibility of the sponsor to ensure the preparation of a final clinical study report as per standards of the GCP guidline format and content of clinical study report . (ICH E3) Monitoring : Monitoring It is the sponsor responsibility to ensure appropriate conduct and monitoring of the study. The monitoring should be carried out by adequately trained monitors or CRO appointed by sponsor, to supervise an ongoing study. Audit : Audit As a part of the QA system, it is responsibility of the sponsor to preform an independent audit by appropriately trained and qualified audit personnel to ensure compliance with the protocol, SOPs, GCPs and applicable regulatory requirement. Role of a Foreign Sponsor : Role of a Foreign Sponsor If the sponsor is a foreign company, organization or perso, it shall appoint a local representaitve or CRO to fulfill the appropriate local responsibilities as governed by the national regualtions. Responsibilities of the Monitor Appointed by the Sponsor : Responsibilities of the Monitor Appointed by the Sponsor The monitor is the principal communication link between the sponsor and the investigator. The monitor should have adequate scientific qualification and practical clinical trial experience. Responsibilities of the Monitor Appointed by the Sponsor : Verification of investigator qualification, expertise and the resources to carry out the study. Availability of investigator throughout the study Adequte and continued availability of institutional facilities like laboratories, equipment, staff, storage space. Responsibilities of the Monitor Appointed by the Sponsor Responsibilities of the Monitor Appointed by the Sponsor (contd……) : Responsibilities of the Monitor Appointed by the Sponsor (contd……) Ensure that the investigational product are supplied only to eligible subjects at the specified dose and time and with proper instruction for handling. Ensure the documentation of the receipt, use, return and disposal of the product at the site. Responsibilities of the Monitor Appointed by the Sponsor Responsibilities of the Monitor Appointed by the Sponsor (contd……) : Responsibilities of the Monitor Appointed by the Sponsor (contd……) Ensure compliance of protocol and maintenance of essential documents by the investigator. Ensure appropriate training and further compliance to the protocol, SOPs and GCP guidelines by investigator and the study team. Responsibilities of the Monitor Appointed by the Sponsor Responsibilities of the Monitor Appointed by the Sponsor (contd……) : Responsibilities of the Monitor Appointed by the Sponsor (contd……) Ensuring that all CRFs are correctly filled out in accordance with original observations consistent with source document. Submitting a written report to the sponsor after each site visit and after all communication as precribed by the SOPs. Responsibilities of the Monitor Appointed by the Sponsor Multicentric Studies : Multicentric Studies In case of multicentric studies, it is responsibility of the sponsor to make special administrative arrangements, appointing a coordinationg committee/coordinator. The sponsor should obtain written aeeptance of the protocol and its annexes from each of the investigator and institution involved Premature Termination or Suspension of a Study : Premature Termination or Suspension of a Study In case the sponsor chooses to or is required to terminate prematurely or suspend the study, then the sponsor should notify the investigator, institution, the ethics committee and the regulatory authorities. The notification should document the reason for the termination by the sponsor or by the investigator/institution. THANK YOU : THANK YOU