INVESTIGATOR AGREEMENT. To be completed by the Investigator I have read Protocol BA058-05-005: “An Extension Study to Evaluate 24 Months of Standard-of-Care Osteoporosis Management Following Completion of 18 Months of BA058 or Placebo Treatment in Protocol BA058-05-003”. I agree to conduct the study as detailed herein and in compliance with ICH Guidelines for Good Clinical Practice and applicable regulatory requirements and to inform all who assist me in the conduct of this study of their responsibilities and obligations. The signature below constitutes my agreement to the contents of this protocol. Signature of Principal Investigator Date Principal Investigator (print) Signature of Sponsor’s Medical Officer (where applicable) Xxxxx Xxxxxxx, MD Date
INVESTIGATOR AGREEMENT. The Investigator is responsible for assuring the proper implementation and conduct of the clinical study including those study-related duties delegated to other appropriately qualified individuals. The Investigator and his/her staff will cooperate with the Sponsor (or an authorized representative) during monitoring and auditing visits to assist with the review of the study data and resolve any discrepancies. The Investigator will demonstrate due diligence in recruitment and screening of potential study subjects. The enrollment rate should be sufficient to complete the study as agreed with the Sponsor (or an authorized representative). The Sponsor (or an authorized representative) is to be notified of any projected delays, which may impact the completion of the study. The Sponsor retains the right to terminate the clinical study at any time for any reason. In such an event, instructions on the requirements for the discontinuation of subjects will be provided by the Sponsor (or an authorized representative).
INVESTIGATOR AGREEMENT. I declare that I have read and approved the protocol set out in this document. I am aware of the responsibility to be assumed as an investigator in accordance with the provisions of the rules of Good Clinical Practice, the Declaration of Helsinki, and the study protocol and I undertake to conduct the study according to the aforementioned directives and to direct and assist the study staff assigned by me. Principal Investigator: Sign Date:
INVESTIGATOR AGREEMENT. I have read the protocol, appendices and procedure manual of the study indicated above. I agree that these documents contain all of the details necessary for me and my staff to conduct this study as described. I agree to conduct the study as described in this protocol and comply with all principles of Good Clinical Practice (GCP), as described in the United States Code of Federal Regulation (CFR) 21 Parts 11, 50, 54, 56, and 312 and the appropriate International Conference on Harmonisation guidance documents. I will provide to all study personnel under my supervision copies of the study protocol, appendices and all other relevant information regarding the study provided to me by the Principal Investigator. I will discuss this material with them to ensure they are fully informed about the study. Investigator (Printed) Date Investigator Name (Signature) Institution (Clinical Site) Sponsor Representative (Printed) Date Sponsor Representative Name (Signature) Abbreviation List Abbreviation Definition CCHMC Cincinnati Children’s Hospital Medical Center CFR Code of Federal Regulation COVID-19 Coronavirus Disease 2019 CRF Case Report Form DMCC Data Management and Coordinating Center GARD Genetic and Rare Disease MERS Middle East Respiratory Syndrome NCATS National Center for Advancing Translational Sciences ORDR Office of Rare Diseases Research PAG Patient Advocacy Groups RD Rare Disease RDCRN Rare Disease Clinical Research Network SARS Severe Acute Respiratory Syndrome
INVESTIGATOR AGREEMENT. I have read this protocol and agree that it contains all necessary details for carrying out this study. I will conduct the study as outlined herein and will complete the study within the time designated. I will provide copies of the protocol and all pertinent information to all individuals responsible to me who assist in the conduct of this study. I will discuss this material with them to ensure that they are fully informed regarding the study drug and the conduct of the study. Coordinating Investigator: Name (typed or printed): Institution and Address: Signature: Date: (Day Month Year) Principal (Site) Investigator: Name (typed or printed): Institution and Address:
INVESTIGATOR AGREEMENT. Summary The Chief Investigator takes ultimate responsibility for the design, conduct, analyses and reporting of a clinical study. The Chief Investigator is also accountable to the University of Manchester (as your employer) for the design, conduct and reporting of a study and, through the University of Manchester, to the sponsor of the research. The Chief Investigator will also be accountable to the care organisation(s) NHS or otherwise where the research is taking place. Chief Investigator Name: Signature: Date: Research Governance, Ethics and Integrity Manager (on behalf of the University of Manchester) Name: Signature: Date: As Chief Investigator, you are responsible for and must ensure that you have the necessary and suitable experience and expertise to design, conduct and report the study to standards set out in the UK policy framework for health and social care research, and all legal and ethical requirements (including by way of example only HRA, REC, MHRA, HTA, NHS R&D organisation). In addition, you must comply with the University of Manchester Policies, and the University of Manchester SOPs and/or SOPS of any other co-sponsor /CTU/Vendors as agreed. Signature of this agreement confirms acknowledgement and compliance with all points raised. As Chief Investigator, you are responsible for and should ensure that you have the necessary and suitable experience and expertise to lead and manage others. You should ensure that:
