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Protocol Guidance - Rater Training - Support - eCOA

Services : Services
Implementation Planning


A Comprehensive Approach

We provide guidance on formulating a standardized training protocol, manual of operations, and study resource documentation to ensure a uniform, consistent process of testing and data collection. We provide:

  • Guidance on outcome measure selection

  • Formulation of standardized training procedures, manual of operations, and study resource documentation to ensure a uniform, consistent process of testing and data collection.

  • Advise on training equipment and needs for individual sites to ensure a standardized protocol while keeping the practicality of testing in mind

  • Creation of an abridged training resource for quick reference for in-study support

  • Guidance in the development of a training video (script, protocol adherence, quality assurance, content, etc.) that outlines the study’s testing protocol as a supplemental resource as needed

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Rater Training

Expert Instruction

We utilize Physical Therapists who are educated, knowledgeable, and experienced in the use of clinical outcome assessments to train, evaluate, and certify each clinical evaluator individually. Our training methods highlight study specifics to ensure the most accurate grading of the outcome assessment. Our training includes:

  • Didactic and practical hands-on training recognizing each individual’s style of learning to maximize the evaluator’s ability to accurately and consistently perform the outcome assessments

  • Applied skills assessments and in-person or remote web-based training/re-training and certification for sites as needed to ensure standard administration of sponsor protocol

  • Certification for each CE trainer that has adequately demonstrated skills to implement testing 

  • Site initiation visits (SIV) and Investigator Meeting (IM) Training/Certification

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The Path to Success

We continue to be ​accessible as a remote resource for clinical evaluators for questions or guidance throughout the study. We provide:

  • Live or remote re-training of clinical evaluators

  • Tracking of re-certification requirements throughout the duration of the study 

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Electronic Clinical Outcome Assessment 

Rater Training and Support - Anytime, Anywhere

​We are experienced in the technology and procedure to remotely assess patients, train CEs, or provide feedback of recorded assessments resulting in more granular endpoint data. We offer:

  • Quality control of outcome assessment data via video review of in-clinic assessments to ensure proper compliance with standardized testing practices

  • Remote assessment of clinical evaluators’ ability to perform the clinical testing to ensure a standardized testing environment and adherence to protocol

  • Remote assessment of patients 

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