Good Clinical Practices
QMRS procedures are written to fulfill the basic requirements of the Good Clinical Practices documentation requirements as stipulated by the International Council for Harmonisation (ICH) guideline for Good Clinical Practices. Nevertheless, QMRS SOPs should not be considered an alternative to the ICH guidance document. Consequently, it is recommended to check the local regulatory authorities’ guidelines to update the contents of these SOPs & Checklists.
Procedures
| Document Description | Price (USD) | Click To Purchase |
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Document Title: Clinical Case Report Form Document Purpose: To provide instructions to Institute “Clinical Research Associates’ and other clinical project team members, on managing and handling clinical case reports.
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63.00 $ |
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Document Title: Clinical Supply Accountability Document Purpose: To describe the accountability requirements for clinical trials supplies.
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84.00 $ |
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Document Title: Clinical Trial Audit Document Purpose: To define the procedure for clinical investigator site auditing to determine that the organization quality management system is fulfilling ICH standard and local regulations.
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94.50 $ |
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Document Title: Clinical Trial Master File Document Purpose: To define the documents that must be retained in the Clinical Trial Master File.
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73.50 $ |
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Document Title: Clinical Trials Confidentiality Agreement Document Purpose: This SOP is to provide a protection of information proprietary to Institute (the corporate). Document Code: CLN-008 Number Of Pages: 4 |
42.00 $ |
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Document Title: Clinical Trials Investigator Responsibilities Document Purpose: To define the responsibilities of the investigator who is involved in clinical research concerning human subjects. Document Code: CLN-007 Number Of Pages: 11 |
105.00 $ |
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Document Title: Clinical Trials Principles Document Purpose: To provide general principles for conducting clinical trials in human subjects Document Code: CLN-001 Number Of Pages: 3 |
31.50 $ |
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Document Title: Clinical Trials Regulatory Requirements Document Purpose: To specify the Regulatory Authorities requirements for conducting clinical trials involving human subjects. Document Code: CLN-002 Number Of Pages: 2 |
31.50 $ |
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Document Title: Clinical Trials Training Requirements Document Purpose: To describe the requirements for clinical trials training, and the procedures to conduct and document clinical training.
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105.00 $ |
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Document Title: Contract Research Organization Document Purpose: This is to specify the procedure for transferring the Institute responsibilities, pertaining to clinical trials activities from Institute to a second party (a Contract Research Organization) Document Code: CLN-003 Number Of Pages: 5 |
52.50 $ |
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Document Title: Contract Research Organization (CRO) Evaluation; Organization Capabilities Checklist Document Purpose: Is to provide the tool for evaluating the Clinical Research Organization Capabilities, based on ICH |
42.00 $ |
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Document Title: Contract Research Organization Evaluation (CRO): Clinical Laboratory Evaluation Checklist Document Purpose: The purpose of this checklist is to provide the tool for evaluating the Clinical Laboratory Capabilities, based on ICH guidelines. |
42.00 $ |
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Document Title: Contract Research Organization Evaluation (CRO): Investigational Site Capabilities Checklist Document Purpose: Is to provide the tool for evaluating the Investigational Site Capabilities, based on ICH guidelines. |
63.00 $ |
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Document Title: Essential Documents Checklist (ICH Parameters) Document Purpose: To specify the documents which should be in place before commencing the Clinical phase of the trial, during the Clinical conduct of the trial, and after completion or termination of the trial. This is to permit evaluation of the conduct of a study and the quality of the data produced. |
84.00 $ |
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Document Title: Informed Consent Form Document Purpose: To provide the essential requirements for writing an informed consent form.
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105.00 $ |
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Document Title: Investigational Product Adverse Event Reporting Document Purpose: This SOP is to describe the procedure for reporting clinical trials adverse events.
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52.50 $ |
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Document Title: Investigational Product Recall Document Purpose: The purpose of this SOP is to outline the processes for recovering investigational product supplies from investigational sites and CROs for quality related withdrawals or product recalls.
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63.00 $ |
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Document Title: Investigator Selection Document Purpose: This document is to describe the process for Investigator selection Document Code: CLN-005 Number Of Pages: 2 |
21.00 $ |
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Document Title: Management of Expired and Extended Investigational Supply Document Purpose: To describe the process and responsibilities for managing expired investigational product and, updating product labels with retest/ expiry dating at an investigational site
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21.00 $ |
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Document Title: Manufacturing of Clinical Supply Document Purpose: To provide the procedure for the preparation (manufacturing) of clinical supplies for clinical trials in human subjects.
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31.50 $ |
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Document Title: Post- Marketing Studies Document Purpose: Is to provide guidance on conducing post-marketing surveillance studies (PMS) for Health Products.
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42.00 $ |
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Document Title: Pre-Trial Documentation Document Purpose: To describe the documentation required from the principle investigator prior to release of clinical product to start the clinical phase of the trial. Document Code: CLN-004 Number Of Pages: 3 |
31.50 $ |
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Document Title: Preparation of Clinical Trial Label Document Purpose: To describe the process for preparing, and approving clinical trial labels, and other printed supplies.
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42.00 $ |
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Document Title: Research Ethics Board Review and Approval Document Purpose: This document is to define the function of the Research Ethics Board (REB) in clinical trials, and to define the relationship among the institution, the investigator and the REB. Document Code: CLN-009 Number Of Pages: 5 |
52.50 $ |
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Document Title: Return and Destruction of Clinical Supplies Document Purpose: To provide the procedure for returning and destruction of clinical trials drug supplies.
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52.50 $ |
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Document Title: Shipment of Clinical Supply Document Purpose: This SOP is to describe the shipping requirements of clinical trials supplies.
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73.50 $ |
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Document Title: Site Master File Document Purpose: To define the documents required to be established and maintained by the clinical investigator before, during, and after the completion or discontinuation of a clinical trial.
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73.50 $ |
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Document Title: Sponsor Responsibilities Document Purpose: To define the Institute responsibilities as a sponsor for conducting clinical trials according to ICH: GCP Guideline. Document Code: CLN-006 Number Of Pages: 13 |
105.00 $ |
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Document Title: Transportation of Blood and Blood Components Document Purpose: The purpose of this procedure is to describe the procedure for the safe transportation of blood and blood components.
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94.50 $ |
