Research Cores - Clinical Research Unit

CRU-3-08 Cognitive Assessments

SOP: 听Cognitive Assessments

Number:
CRU-3-08		 Date:
Version 2.0,
06/Mar/2026		 Supersedes:
Version 1.0,
05/Nov/2024		 Responsible Authority:
CRU Director		 Page 1 of 3

  1. PURPOSE

    The purpose of this SOP is to describe the procedures to be followed when administering cognitive assessment(s) to participants and to ensure testing consistency and accuracy.

  2. REVISIONS FROM PREVIOUS VERSION

    2.1 听Version 1.0, 23Sept2024: Initiation of new SOP.

    2.2 听Version 2.0, 06/Mar/2026: reviewed the SOP, updated version number and date, removed Associate Director from the SOP, added Research Assistant and CRU staff to the SOP.

  3. POLICY

    N/A

  4. RESPONSIBILITIES

    4.1 听CRU Director

    1. 4.1.1 听Oversee the cognitive testing process.
    2. 4.1.2 听Work with the principal investigator (PI) to ensure that all study personnel receive the training necessary to accurately perform cognitive testing.
    3. 4.1.3 听Ensure that training certificates are appropriately stored in study regulatory binder and/or credentials binder.
    4. 4.1.4 听Ensure to provide a quiet, distraction-free environment.
    5. 4.1.5 听Secure necessary resources, including study personnel, to support cognitive assessment(s) for research studies.
    6. 4.1.6 听Establish and maintain quality control measures to ensure accuracy and reliability of cognitive assessment(s).
    7. 4.1.7 听Ensure informed consent has been obtained from participants and/or their legal representatives prior to performing cognitive assessment(s).
    8. 4.1.8 听Ensure compliance with the protocol and address any issues that may arise during the cognitive assessment process.

    4.2 听CRU Research Coordinator/Research Assistant/Research Nurse/CRU staff

    1. 4.2.1 听Ensure that the protocol and cognitive assessment(s) have been approved by the IRB.
    2. 4.2.2 听Ensure that participants and/or their legal representatives signed informed consent prior to beginning the cognitive assessment(s).
    3. 4.2.3 听Ensure that participants and/or their legal representatives understand the purpose of the cognitive assessment(s), potential risks, benefits, and right to refuse or withdraw.
    4. 4.3.4 听Follow standardized procedures outlined in the cognitive assessment(s) instructions to ensure reliability and validity of test results.
    5. 4.3.5 听Provide appropriate accommodations based on the participants' needs during the testing session to ensure that they are comfortable.

    4.3 听Principal Investigator

    1. 4.3.1 听Ensure that the protocol and cognitive assessment(s) have been approved by the IRB.
    2. 4.3.2 听Ensure that all study personnel have received the necessary training on the protocol and cognitive assessment(s).
    3. 4.3.3 听Oversee the cognitive testing process, as well as the collection, entry, and correction of all data obtained during the cognitive assessment(s).
    4. 4.3.4 听Ensure that participants and/or their legal representatives signed informed consent prior to cognitive assessment(s).
    5. 4.3.5 听Ensure that participants and/or their legal representatives understand the purpose of the assessment, potential risks, benefits, and right to refuse or withdraw.

  5. PROCEDURE

    5.1 听Ensure all necessary test materials are gathered and available in the room prior to beginning the cognitive assessment(s).

    5.2 听Ensure that the room is quiet, private, well-lit, and distraction-free.

    5.3 听Offer snacks and/or water prior to testing and during the assessment(s) and ensure that participants are comfortable.

    5.4 听Provide clear and concise instructions for each cognitive test, following the standardized procedures outline in the test instructions.

    5.5 听Use language that is appropriate for participants, based on their age, education level, and cognitive abilities.

    5.6 听Answer any questions the participant may have regarding instructions before proceeding to the test.

    5.7 听Strictly adhere to the specified time limits for each test question. Use a timer or stopwatch to ensure accuracy.

    5.8 听Administer assessment(s) in the recommended order.

    5.9 听If a participant requests clarification on a test item, provide a neutral response without giving hints or suggestions. Refer the participant back to the original instructions.

    5.10 听When the testing visit is finished, ensure that each assessment has been fully completed and scored according to the instructions.

    5.11 听Answer any questions that a participant may have about the test and/or assessment process, if applicable.

    5.12 听Write participant ID, visit number, date, and your initials on the top of each page of the visit packet. Ensure that scoring is clear and concise.

    5.13 听Ensure to enter the data into REDCap, or any other platform used for study data collection, by the end of the day.

    5.14 听Ensure that all documents are stored securely, in a locked cabinet, in a locked room.

  6. REFERENCES

    6.1 听Alzheimer's Association

SIGNATURES

Prepared by: Judyta A. Kociolek, MSN, RN
Director of CRU Operations
Date: 10 Mar 2026

Approved by: Peter J. Holland, MD
CRU Medical Director
Date: 10 Mar 2026

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