**16. Conclusion**

• Compliance with ethics

38 Clinical Trials in Vulnerable Populations

*guardian.*

*decide.*

• Correspondence

*institute.*

• Trial data documentation

• Preparing the final report

*Give adequate information to the subjects and legal guardians about study procedure, harms, and benefits of the intervention. Also, give adequate information to the subjects and legal guardians about responsibility and rights of each side. Then, obtaining freely signed informed consent form from legal* 

*The researcher should also spend sufficient time for participants and allow participants themselves to* 

*The investigator should ensure that the subjects are correctly diagnosed and reduce the known kinds of biases including random bias and selection bias with adhering to clinically sound diagnosis, randomiza-*

*The main objective of performing a clinical trial is usually assessing the effectiveness of a product at a specific dose. But, the phase II clinical trials are dominantly aim at the determination of appropriate or safe dose ranges. Hence, determining appropriate dose and timing of product intake based on previous* 

*The main investigator is responsible to correspond with the sponsor, ethics committee, and research* 

*The researcher must make sure that the participant's identification, trial observations, findings, and also side effects are recorded correctly and completely in a paper-based or computer-based case report* 

*Laboratory values within or outside the normal reference ranges, if possible together with the specificity and sensitivity of the methods used, should always be recorded on the CRF or be attached to it.*

*Suitable place for archiving and confidentiality of the data should be guaranteed by the investigator.*

*The project should be based on the Gantt chart and the sponsor-approved budget. Then, the final report of the trial should be prepared as defined in the protocol. The report should be signed by the sponsor, monitor, and investigator(s) as well as the responsible statistician, in accordance with the relevant regulations.*

*form (CRF). Furthermore, the investigator should fill and maintain investigator's file.*

• Unbiased selection/randomization, blinding, and allocation concealment

*tion, blinding, and allocation concealment. These processes are discussed before.*

• Obtaining oral assent from the children and adolescents

• Be sure that dosage and instruction for use are correct

*studies and literature is very important.*

• Monitoring and follow-up potential side effects

• Secured storage and limited access to data

*Adverse effects must be reported and monitored until its removal.*

• Laboratory quality assurance/quality control (normal lab values)

Clinical trial in children and adolescents as a vulnerable population is a great concern to the legal guardians, medical investigators, and ethics committees. These trials must be planned, set up, conducted, documented, and reported in a great standard named good clinical practice. The data should be collected, synthesized, and documented with accuracy and consistency. Furthermore, researches involving humans especially those with low perception including psychiatric patients and children, and adolescents should be scientifically sound and conducted in accordance with high ethical standards. Obtaining written freely signed informed consent form from parents or legal guardians is mandatory in clinical trials performing on children and adolescents. Additionally, obtaining oral assent from the subject itself is essential too. Institutional ethics committees are responsible for approving the trial methodology and safety in a way that ensure protecting of patient's rights and health. Meanwhile, monitoring would help to guarantee the maximum quality of data and wellbeing of subjects. Monitoring the clinical trial is the process of auditing trials based on the sponsor-approved protocol and the standard of good clinical practice. In all, the concept of good clinical practice in children and adolescents necessitates medical researchers a binding statement: "Performing the trial with best possible standards and optimum health of my patient will be my first consideration."
