**12. Monitoring**

Monitoring is an important part of good clinical practice. Monitoring is the process of auditing the trial based on compliance to the approved protocol, ethics, and regulation in a way that guarantee the optimum health and rights of the subjects, as well as timely submission of high-quality data. The objectives of monitoring are to prevent, detect, and correct careless errors, neglect, fraud/misconduct, and violations. Monitoring will guarantee the quality of medical care, quality of data, quality of trial, and quality of product. The monitor is a person who has been chosen by the sponsor or research institute for the monitoring and reporting of progress of the trial and for the confirmation of data. The monitor should have enough medical, scientific, and/or pharmaceutical qualifications, and clinical trial experience [21].

#### **12.1. Monitor's responsibilities**

Monitor's responsibilities are listed below:

• To act as a soother between the sponsor and the investigator

*The inspector is chosen by sponsor and is responsible for corresponding between sponsor and investigator.*

• To help the investigators on all aspects

*Helping investigators in providing supplies and solving problems is among the responsibilities of the inspector.*

• To help protection of study subjects

*Confirming obtain of informed consent for all subjects prior to their participation in the trial is one of the monitors responsibilities.*

• To verify adequacy of trial resources

*Monitor check for adequacy investigators, staff, and facilities before and throughout the study period.*

• To verify supply, control, storage, and disposition of investigational product/s

*Turning back additional materials after the trial is finished is one of the inspector's duties.*

• To verify adherence to the approved protocol/amendments

*Adherence to the approved protocol ensures that data are correctly gathered and reported. Any changes to the protocol should be documented and reported.*

• To verify adherence to good clinical practice and standard operating procedures

*Standard operating procedure (SOP) is a standard comprehensive framework for administration of clinical trials.*

• To monitor recruitment rate, safety evaluation, and compliant observations

*Validity and quality of data gathered and safety of patients are monitored by the inspector during the trial.*

• To check the accuracy and completeness of all trial data and case report forms

*Case report form is a paper-based or computer-based sheet that is used to record and gather the data on each trial subject during the trial, as defined by the protocol. The documentation should allow easy access for verification, audit, and inspection.*

• To discuss study plan and problems with main investigator and staff

*Monitors are trained in clinical trial and medical research and may collaborate to improve the quality of trial. They may also verify that trial documents are complete and up-to-date [25].*

### **13. Monitoring visits**

**11. Reports**

34 Clinical Trials in Vulnerable Populations

the trial [21].

**12. Monitoring**

**12.1. Monitor's responsibilities**

*investigator.*

*inspector.*

Monitor's responsibilities are listed below:

• To help the investigators on all aspects

• To help protection of study subjects

• To verify adequacy of trial resources

*the monitors responsibilities.*

• To act as a soother between the sponsor and the investigator

Moving in accordance with protocol allows its accurate reporting, interpretation, monitoring, and verification of the trial. Furthermore, it assures the quality of every aspects of the trial. The data obtained from the trial must be handled, analyzed, synthesized, and reported in a sound approach. In addition, the sponsor or the research institute should be able to carry out on-site inspections of the validity of reported results. Hence, brilliant documentations and reporting are very important as well as the monitoring processes. For this purpose, the research institute should have easy access to all patient files and raw data during

Monitoring is an important part of good clinical practice. Monitoring is the process of auditing the trial based on compliance to the approved protocol, ethics, and regulation in a way that guarantee the optimum health and rights of the subjects, as well as timely submission of high-quality data. The objectives of monitoring are to prevent, detect, and correct careless errors, neglect, fraud/misconduct, and violations. Monitoring will guarantee the quality of medical care, quality of data, quality of trial, and quality of product. The monitor is a person who has been chosen by the sponsor or research institute for the monitoring and reporting of progress of the trial and for the confirmation of data. The monitor should have enough medi-

cal, scientific, and/or pharmaceutical qualifications, and clinical trial experience [21].

*The inspector is chosen by sponsor and is responsible for corresponding between sponsor and* 

*Helping investigators in providing supplies and solving problems is among the responsibilities of the* 

*Confirming obtain of informed consent for all subjects prior to their participation in the trial is one of* 

*Monitor check for adequacy investigators, staff, and facilities before and throughout the study period.*

#### **13.1. Pretrial monitoring visit**

During prestudy visit, the monitor ensures feasibility of trial in the center and interest of the investigator. Also he/she makes sure that the investigator understands the required "trial procedures" and sufficient site staff, proper facilities, location, equipment, laboratory, product storage, and archive exist to support the study.

The inspector may discuss with investigator(s) about


The audit may clarify any issues that remain uncertain, regulatory requirement and fulfills the sponsor expectations. He/she may document any changes in the protocol to eliminate practical defects.

• Protocol compliance: strictly follow protocol procedures, alteration

**14. Responsibilities of the investigators after approvals**

*The main investigator should sign and hereby accept the responsibility of trial.*

• Registering the protocol of the trial in one of the clinical trial registries

*journal. He/she must also agree with publication policy of journal and publisher.*

*The investigator should collaborate in on-site inspections and in corresponding.*

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

• Adherence to the protocol and good clinical practice principles

• Adhering to administrative and regulatory requirements

• Work according to the protocol and good clinical practice guidelines

*forms to the sponsor, the research institute and ethics committee.*

Make sure the investigator file is archived properly and collects back all unused materials,

Good Clinical Practice in Children and Adolescents http://dx.doi.org/10.5772/intechopen.70191 37

*The main investigator should provide the requested form including budget, Gantt chart, and consent* 

*Now most high-quality journals necessitate researchers to submit their work in one of clinical trial registries before patient's enrollment into the trial and provide its code at the time of submission to the* 

*The investigator must ensure that he/she acts in accordance with the sponsor-approved protocol and* 

*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.*

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

• Sponsor approval

**13.4. Close-out visit**

documents, or products.

• Sign the final copy of protocol

• Submit the requested document

*globally accepted standard of GCP.*

• Collaborate with monitor

#### **13.2. Trial initiation visit**

Deliver study material, documents, and products, and make sure the investigational team understands the protocol and good clinical practice requirements.

The responsibilities of the inspector in trial initiation visit are listed below:


#### *Discuss in detail:*


#### **13.3. Monitoring visit**

In approach to help the investigational team in solving problems, the trained audits would make sure that the study is conducted in accordance with the requirements of the protocol and good clinical practice principles. Also they make sure that investigators are available during the visits.

*Discuss:*


The audit may clarify any issues that remain uncertain, regulatory requirement and fulfills the sponsor expectations. He/she may document any changes in the protocol to elimi-

Deliver study material, documents, and products, and make sure the investigational team

In approach to help the investigational team in solving problems, the trained audits would make sure that the study is conducted in accordance with the requirements of the protocol and good clinical practice principles. Also they make sure that investigators are available during the visits.

• Obtaining assent from the children and adolescents (process by which patient/subject vol-

understands the protocol and good clinical practice requirements.

The responsibilities of the inspector in trial initiation visit are listed below:

nate practical defects.

36 Clinical Trials in Vulnerable Populations

**13.2. Trial initiation visit**

• Revise team training

*Discuss in detail:*

• Endpoints

• Patients safety

• Ensure understanding of protocol

• Ensure safety reporting procedure

• Enrollment and exclusion criteria

• Criteria for grading adverse effects

• Handling of patient samples

• Standard operating procedures

• Obtaining informed consent from legal guardian

untarily confirms his/her willingness to participate)

• Handling of test product

**13.3. Monitoring visit**

*Discuss:*

• Problems

• Modifications

• Ensure ethical requirements

• Ensure understanding of case report form

#### **13.4. Close-out visit**

Make sure the investigator file is archived properly and collects back all unused materials, documents, or products.
