Laboratory Specimen in clinical research refers to the sample of a participant’s tissue, fluids and any other material used for laboratory analysis to assist in diagnosing any illness/disease throughout participating in any study.
The extraction of human samples is regulated by internal and external laws that protect the participants’ rights. Informed consent is obtained and signed by the participant before the nurse or doctor can collect any specimen for a study. In a case where a minor is concerned, the parent or guardian needs to consent for the specimen to be collected from an infant/child/adolescent.
In addition, international laws specify when the specimen may, if necessary, be shipped to another nation. The Sponsor and the Principal Investigator will engage in a “Material Transfer Agreement”. Furthermore, the Principal Investigator must apply for an ‘Export Permit’ from the Department of Health to ship the specimen to a lab in another country specified by the Sponsor.
The specimen will then go through the ‘International Air Transport Association’, which is an international trade body created over 69 years ago by a group of airlines and represents more than 240 countries.
This Association aims to uphold good specimen collection, packaging, labelling and transportation of different types of specimens to different Laboratories all over the world and not compromise the quality of specimens during transportation.
During a clinical trial, all research participants are assigned a unique number which protects the identity of a participant and maintains the confidentiality of all information collected. The different specimens collected during a clinical trial are labelled with that number and the participant cannot be traced outside of the Research Site.
Examples of specimens collected during a clinical trial include blood, urine, faeces, cervical fluids, saliva, and perineal/perianal/penile fluids collected using swabs.
The process of taking laboratory samples from participants is extremely important and, if not done properly, results may be unclear or faulty. Thus, only medical experts (such as nurses and doctors) are authorised to collect any lab specimen from different people or voluntarily participants.
After the extraction of the specimen is done, the specimen collected is labelled and packaged according to different specifications. They are then stored in the current temperature while awaiting collection to the Laboratory. The specimen is only collected by the specialised courier services which deliver to the Laboratory.
Once the laboratory has tested all specimens, the results are then delivered via email or hardcopy to the research site for distribution to the participant. The assigned staff member/doctor will print the results and communicate them to the participant at their next visit.
However, if the results require urgent discussion or attention, the participant will immediately be contacted.
Although the participant may feel uncomfortable during the extraction of laboratory specimens, professionals conducting these procedures are experienced. These processes ensure that the disease/illness is diagnosed from quality specimens. These will help in treating participants while they are ‘asymptomatic’ in the latent phase of the disease.
