Full Protocol and Protocol Update Certificate docx 2025

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The document is a Certificate of Completion for a training protocol, including sections for trainee, trainer, and medical director signatures. It outlines the requirement for signatures from both the trainer and medical director if the trainee is affiliated with an EMS agency providing Advanced Life Support (ALS) services.
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  1. Click ‘Get Form’ to open the Full Protocol and Protocol Update Certificate in the editor.
  2. Begin by entering your name in the designated (NAME) field, followed by your service in the (SERVICE) field. This personalizes the document for your records.
  3. In the 'Protocol Update' section, fill in the version number and year of completion. This ensures that all updates are accurately documented.
  4. Next, sign in the 'TRAINEE SIGNATURE' field and enter the date completed. This confirms your participation in the training.
  5. Proceed to have your trainer sign in the 'TRAINER SIGNATURE' field along with their date of completion. This validates your training process.
  6. Finally, ensure that a Medical Director signs in the 'MEDICAL DIRECTOR SIGNATURE' field if applicable, confirming compliance for ALS services.

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Provided preferably on a separate page, it should summarize all the central elements of the protocol, for example the rationale, objectives, methods, populations, time frame, and expected outcomes. It should stand on its own, and not refer the reader to points in the project description.
The protocol is the working document that describes the objective(s), design, methodology, statistical considerations, and organization of a clinical research project as well as the background and rationale for the trial.
Its important to take users, use cases, risks and threats into account when designing the protocol. Consider the unique threat model of the protocol, defining that threat model clearly, and ensuring that the protocol addresses the most important identified threats.
Protocol summary: Give a concise overview of the project. Describe the purpose of the study, including problem to be investigated and hypothesis(es) to be tested, the population, and the methods that will be used. Avoid the use of acronyms. Include the expected benefit of the study.
For example, changes requiring an amendment to an IND application may include: Any increase in drug dosage or duration of exposure of individual subjects to the drug beyond that described in the current protocol, or any docHub increase in the number of subjects under study.

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The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.

Related links

Protocol Template - NIH Office of Science Policy

Investigators for such trials are encouraged to use this template when developing protocols for NIH-funded clinical trial(s). This template may also be useful

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