902 Twenty Four Hour Urine Collection

Purpose

To ensure the Principal Investigator (PI) and all research team members assisting with the conduct of clinical research at the Ohio University Heritage College of Osteopathic Medicine’s Clinical and Translational Research Unit (CTRU) are informed about their obligations and responsibilities as they pertain to Good Clinical Practices (GCP), the investigational plan, applicable regulations, and institutional policies.

This Standard Operating Procedure (SOP) describes the procedures for the proper collection of 24-hour urine samples from research participants.

Responsibilities

The CTRU is responsible for developing, implementing, and maintaining SOPs. Creating new or revising an existing SOP is determined by changes to federal regulation, guidelines, institutional policies, or procedures. All applicable documents will be provided to departments and research teams conducting human subject research.

Procedures

1. Study Protocol

• The investigator or delegated study staff are responsible for instruction and processing the collection of the 24-hour urine sample.
• Collection of the sample will be performed as specified by the study protocol.
• If the study protocol does not provide specific requirements, then the investigator or delegated study staff will follow the procedure below.

2. Safety

• Personal protective equipment is required when handling urine samples: latex-free gloves, lab coat, etc. Surfaces will be cleaned with Cavicide or disinfectant wipes and urine containers will be properly exposed in biohazard containers after use.

3. Supplies

• Urine collection container (“hat” for females).
• Two urine storage containers.
• A permanent marker.
• An instruction sheet for participant.

4. Preparation

• Assemble the appropriate supplies.
• Label the urine storage container with appropriate participant information (e.g. study name, subject ID#, subject initials).

5. Procedures

• Participant instructions
  • Start 24-hour urine test by urinating directly into toilet. Do not save this first urine. After this urination, write the date and time on the storage container with a permanent marker.
  • For each urination over the next 24 hours, urinate into the collection container, then pour the urine into the storage container. Males can urinate directly into storage container if preferred.
  • Keep storage container refrigerated or on ice throughout the 24-hour collection period until returned to the Clinical & Translational Research Unit (CTRU).
  • When one container is full, place urine in a second storage container.
  • Exactly 24 hours after the test started, urinate one last time and place the urine in the storage container. This marks the end of the test.
  • Write the date and time of final urine collection on the storage container with a permanent marker.
  • Follow instructions on how and where to transport specimen such as: ensure lid is on tightly and transport container upright in a plastic bag.
  • Return storage container to CTRU within 24 hours.
  • Instruct participant when to begin 24-hour-urine test (days and times) so that return of sample will coincide with CTRU’s hours of operation (e.g. Do not start 24-hour urine test on a Friday or Saturday since CTRU is closed weekends and cannot accept samples. Likewise, do not begin urine collection during the evening hours since CTRU is closed in the evenings and cannot accept samples).
  • If the participant is not able to collect every sample (e.g. a sample spills or a urine sample is missed), instruct participant to stop the test and restart the test on a different day.
• Processing of sample
  • Put on protective gloves.
  • Gently mix the entire specimen.
  • Measure and record the total volume.
  • Obtain urine samples as specified by the study protocol.
  • Discard remaining urine in toilet
• Suggested Informed Consent Language

You will be asked to collect a 24-hour urine specimen. You will be given an instruction sheet and a container in which to collect the urine. You should begin collecting urine the day before your clinic visit. To collect the urine, discard the first urine of the day, and then save all urine for the next 24 hours. The urine should be kept refrigerated or on ice.

References: None

Attachments: None

Appendices: None

Approver: Director, CTRU and Clinical Partnerships