CRU-3-08 Cognitive Assessments

SOP: Cognitive Assessments
NUMBER DATE SUPERSEDES RESP. AUTHORITY PAGE
CRU-3-08 Version 1.0, 05/Nov/2024 N/A CRU Director 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 Version 1.0, 23Sept2024: Initiation of new SOP

3 POLICY

N/A

4 RESPONSIBILITIES

4.1 CRU Director or Assistant Director

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

4.2 CRU Research Coordinator/Research Nurse

  • 4.2.1 Ensure that the protocol and cognitive assessment(s) have been approved by the IRB.
  • 4.2.2 Ensure that participants and/or their legal representatives signed informed consent prior to beginning the cognitive assessment(s).
  • 4.2.3 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.
  • 4.3.4 Follow standardized procedures outlined in the cognitive assessment(s) instructions to ensure reliability and validity of test results.
  • 4.3.5 Provide appropriate accommodations based on the participants' needs during the testing session to ensure that they are comfortable.

4.3 Principal Investigator

  • 4.3.1 Ensure that the protocol and cognitive assessment(s) have been approved by the IRB.
  • 4.3.2 Ensure that all study personnel have received the necessary training on the protocol and cognitive assessment(s).
  • 4.3.3 Oversee the cognitive testing process, as well as the collection, entry, and correction of all data obtained during the cognitive assessment(s).
  • 4.3.4 Ensure that participants and/or their legal representatives signed informed consent prior to cognitive assessment(s).
  • 4.3.5 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 Ensure all necessary test materials are gathered and available in the room prior to beginning the cognitive assessment(s).
  • 5.2 Ensure that the room is quiet, private, well-lit, and distraction-free.
  • 5.3 Offer snacks and/or water prior to testing and during the assessment(s) and ensure that participants are comfortable.
  • 5.4 Provide clear and concise instructions for each cognitive test, following the standardized procedures outlined in the test instructions.
  • 5.5 Use language that is appropriate for participants, based on their age, education level, and cognitive abilities.
  • 5.6 Answer any questions the participant may have regarding instructions before proceeding to the test.
  • 5.7 Strictly adhere to the specified time limits for each test question. Use a timer or stopwatch to ensure accuracy.
  • 5.8 Administer assessment(s) in the recommended order.
  • 5.9 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 When the testing visit is finished, ensure that each assessment has been fully completed and scored according to the instructions.
  • 5.11 Answer any questions that a participant may have about the test and/or assessment process, if applicable.
  • 5.12 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 Ensure to enter the data into REDCap, or any other platform used for study data collection, by the end of the day.
  • 5.14 Ensure that all documents are stored securely, in a locked cabinet, in a locked room.

6 REFERENCES

6.1 Alzheimer's Association

SIGNATURES

Prepared by: Judyta A. Kociolek, MSN, RN, Director of CRU Operations
Approved by: Peter J. Holland, MD, CRU Medical Director

Executed signature pages are available in the Initiating Authority Office