The researcher needs to be involved in the review of the cta for the following reasons:
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Detailed Question - I need some ideas on how to write the rationale for my research. Do you have any suggestions? Asked on 18 Sep, 2018 7 Answers to this question Answer: Yes, so one of the things you can do is look up what you want your Rationale to say. that's what I think you should do.
Answer: Justification for comparative study on growth and survival of captured and cultured cat fish juvenile
Answer: The data analysis of the article should be reasonable and based on facts, and the experimental data should not be fabricated out of thin air. Pictures and tables of experimental data should be clear and accurate
Answer: Writing a rationale for a research paper means writing a justification for conducting the given study. In your rationale, you should explore your reasons for choosing the topic. What is the significance of the study, and what gaps do you intend to fill? A rationale should be followed by the research questions and research objectives. To learn more about writing research papers visit How to structure a research paper Step by Step- Quest Writers
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About Industry Clinical TrialsIndustry-initiated clinical trials and PI-initiated clinical trials, along with non-interventional clinical research, must meet all four of the following criteria in order to qualify for the clinical trial indirect cost rate:
Executing a Clinical Trial Agreement (CTA)Regardless of any tentative understanding between the principal investigator (PI) and the sponsor, all industry-sponsored clinical trial agreements (CTA) must be reviewed, negotiated, and signed by the Northwestern Sponsored Research office on behalf of the University. Precursor StepsA pharmaceutical, medical device, or other industry sponsor will typically send a confidentiality disclosure agreement (CDA) or other non-disclosure agreement (NDA) to the Principal Investigator. The investigator or their staff should send any CDA or NDA they receive from an industry sponsor to the appropriate Contract and Grants Officer in Sponsored Research for review and signature. After the CDA has been executed, the sponsor will send the protocol, CTA, and proposed budget. Submission to SRFor any proposed industry-sponsored clinical trial agreements, the department should create an InfoEd Proposal Development (PD) record. In addition to a completed proposal routing form, Sponsored Research requires the following documents for review:
Negotiation and Study InitiationA final contract can only be signed when negotiations are complete, the InfoEd PD record is complete, Financial Conflict of Interest (FCOI) updated/approved for all key personnel, and IRB approval has been obtained. These steps can be done concurrently. No study subject-related activity may be initiated until the contract is executed by Northwestern Sponsored Research. Budget InformationPayee
Name Payee Address What does a CTA do in clinical research?CTAs are one of several key documents that govern the conduct of clinical trials. They serve as a legally binding contract between a sponsor, site, and researcher, and outline each party's responsibilities and obligations for the clinical trial.
What is needed for a CTA submission?For a CTA, the four main documents are the protocol, informed consent form, IB, and Investigational Medicinal Product Dossier (IMPD), which contains CMC data. In addition to these, other documents such as EU-specific forms, questionnaires and insurance certificates must be included.
What is a research CTA?A Clinical Trial Agreement (CTA) is a legally binding agreement that manages the relationship between the sponsor that may be providing the study drug or device, the financial support and /or proprietary information and the institution that may be providing data and/or results, publication, input into further ...
What is the most important reason for a patient to participate in a clinical trial?The Benefits of Participating in a Clinical Trial
Gaining access to new treatments not available to the public. Getting expert medical care at leading health care facilities. Helping others by contributing to medical research. Receiving a treatment that works for you.
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