Trto SOP Quiz: V-15 Specimen Collection And Handling

1.

Per SOP V-15, what is the first step required when collecting specimens for subject in a clinical trial?
- A.
  
  Check the protocol, procedure manual, or manual of operations to determine the types of specimens required.
- B.
  
  Check that the subject has a current signed informed consent on file.
- C.
  
  Schedule specimen collection with the appropriate lab
Correct Answer
B. Check that the subject has a current signed informed consent on file.

Explanation
The correct answer is to check that the subject has a current signed informed consent on file. This is the first step required when collecting specimens for a subject in a clinical trial because it ensures that the subject has given their voluntary and informed consent to participate in the trial and have their specimens collected. Without a signed informed consent, it would be unethical to proceed with specimen collection. Checking the protocol, procedure manual, or manual of operations to determine the types of specimens required and scheduling specimen collection with the appropriate lab are important steps, but they can only be done after confirming that the subject has a current signed informed consent on file.

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2.

How should specimens that are sent off-site be tracked?
- A.
  
  By using a specimen shipping log, confirming the specimens' arrival at the destination, and filing information in study binders.
- B.
  
  By using a specimen shipping log, alerting the lab of specimen shipment, and filing information in study binders.
- C.
  
  By using a specimen shipping log, a confirmation of receipt log, and filing information in study binders.
Correct Answer
A. By using a specimen shipping log, confirming the specimens' arrival at the destination, and filing information in study binders.

Explanation
The correct answer is to track specimens that are sent off-site by using a specimen shipping log, confirming the specimens' arrival at the destination, and filing information in study binders. This method ensures that there is a record of the specimens being shipped, their arrival at the destination, and the necessary information is documented for future reference in study binders. It allows for proper tracking and organization of the specimens throughout the process.

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3.

TRUE or FALSE: All individuals shipping specimens from CCHMC must be IATA certified to handle specimens.
- A.
  
  True
- B.
  
  False
Correct Answer
A. True

Explanation
All individuals shipping specimens from CCHMC must be IATA certified to handle specimens. This means that anyone involved in the process of shipping specimens, such as packaging, labeling, and handling, must have completed the necessary training and certification provided by the International Air Transport Association (IATA). This certification ensures that individuals are knowledgeable about the regulations and requirements for safely shipping specimens, including proper packaging and handling procedures to prevent any potential hazards during transportation.

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4.

Per SOP V-15, what is the minimum information that should be completed on the specimen tube's label?
- A.
  
  Date, time, subject identifier, subject initials
- B.
  
  Date, time, subject identifier, required information
- C.
  
  Date, time, subject identifier
Correct Answer
B. Date, time, subject identifier, required information

Explanation
The correct answer is "Date, time, subject identifier, required information". According to SOP V-15, the minimum information that should be completed on the specimen tube's label includes the date, time, subject identifier, and any other required information. This ensures that the specimen can be properly identified and tracked, and that all necessary information is provided for accurate analysis and documentation.

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5.

To whom does SOP V-15 apply?
- A.
  
  All study team members involved in ensuring appropriate specimen collection and handling
- B.
  
  All TRTO members
- C.
  
  Only those TRTO members involved in ensuring appropriate specimen collection and handling
Correct Answer
C. Only those TRTO members involved in ensuring appropriate specimen collection and handling

Explanation
SOP V-15 applies only to those TRTO members who are involved in ensuring appropriate specimen collection and handling. This means that not all study team members are required to follow this SOP, but only the specific TRTO members who have responsibilities related to specimen collection and handling.

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Trto SOP Quiz: V-15 Specimen Collection And Handling

Per SOP V-15, what is the first step required when collecting specimens for subject in a clinical trial?

How should specimens that are sent off-site be tracked?

TRUE or FALSE: All individuals shipping specimens from CCHMC must be IATA certified to handle specimens.

Per SOP V-15, what is the minimum information that should be completed on the specimen tube's label?

To whom does SOP V-15 apply?