**15. Responsibilities of the investigators during study**

• Adherence to the protocol and good clinical practice principles

*The investigator should adhere to the inclusion and exclusion criteria mentioned in the approved protocol. He/she has overall responsibility for ensuring the accuracy and completeness of data gathered.*

#### • Adhering to administrative and regulatory requirements

*Local regulations and administrative requirements should also be respected by the investigators.*

#### • Compliance with ethics

*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 guardian.*

**16. Conclusion**

patient will be my first consideration."

Mohammad Reza Mohammadi\* and Seyed-Ali Mostafavi\*

developing countries. Vaccine. 2007;**25**(15):2852-2857

\*Address all correspondence to: mostafavi.n80@hotmail.com; mohammadimr@tums.ac.ir

Psychiatry and Psychology Research Centre, Roozbeh Hospital, Tehran University of Medical

[1] Acosta CJ, et al. Implementation of good clinical practice guidelines in vaccine trials in

[2] Kious BM. The Nuremberg code: Its history and implications. Princeton Journal of

[3] Vijayananthan A, Nawawi O. The importance of good clinical practice guidelines and its role in clinical trials. Biomedical Imaging and Intervention Journal. 2008;**4**(1):e5

[4] The World Medical Association. Declaration of Helsinki [Internet]. 2004. Available from:

**Author details**

Sciences, Tehran, Iran

Bioethics. 2001;**4**:7-19

http://www.wma.net/e/policy/b3.htm

**References**

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

Good Clinical Practice in Children and Adolescents http://dx.doi.org/10.5772/intechopen.70191 39

#### • Obtaining oral assent from the children and adolescents

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

#### • Unbiased selection/randomization, blinding, and allocation concealment

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

#### • Be sure that dosage and instruction for use are correct

*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 studies and literature is very important.*

#### • Correspondence

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

#### • Monitoring and follow-up potential side effects

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

#### • Trial data documentation

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

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

*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.*

#### • Secured storage and limited access to data

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

#### • Preparing the final report

*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.*
