Clinical Research Associate (CRA)

1. Principal Investigator (PI)

1.1. pre-study phase

1.1.1. assessment of PI's interest in the study

1.1.2. investigator learning more about study drug/device, study design, protocol, and the sponsor

1.1.3. PI is provided with the study protocol and investigator's brochure

1.1.4. after sponsor has sufficient time to review documents, an agreement between the sponsor and PI is finalized outlining the responsibilities of the PI

1.2. during the trial

1.2.1. PI is informed about any changes in the protocol and if the protocol is prematurely terminated or suspended.

1.2.2. verification that the staff are performing their responsibilities as delegated

1.2.3. maintenance of source documents and other trial records are verified

1.2.4. essential documents from the REB and regulatory authorities are verified

1.2.5. verification that only eligible patients have been enrolled in the trial and informed consent are obtained

1.2.6. verification that all adverse events have been reported and within the required time period

1.2.7. verification that CRFs are completely accurate and consisted with source documents

1.2.8. verification that the study drug is stored, dispensed and destroyed appropriately

1.2.9. notifications with findings that could adversely affect safety of subjects, impact the conduct of trial, or alter the REB's favourable opinion to continue the trial.

1.3. post-trial phase

1.3.1. responsibilities for storing trial documents, returning of study supplies, return or disposal of the study drug are confirmed

1.3.2. one last review of the regulatory documentation

1.3.3. notification that the clinical trial is complete

1.3.4. confirmation that the study has met all requirements

1.3.5. trial reports that details the results and their interpretation will be prepared in accordance with regulatory requirements

2. Clinical Research Coordinator (CRC)

2.1. ensures that all members of the research team are in compliance with rules and regulations that must be followed in the duration of the trial

2.2. keeping a careful eye on subject care, such as that patients must be given excellent medical care and evaluation to identify any AE including accurate and expedited reporting of SAEs

2.3. gathering of regulatory documentation that the study site might need and keep on site

2.4. overall management of the trial at the study site

2.5. determination whether study site will be able to meet the recruitment goals

2.6. A Trial Master files are established at the site, including pertinent documents related to the trial

2.7. if compensation are provided to participants, the method and manner in which trial subjects receive compensation complies with applicable regulation

3. Statistician

3.1. in the post-trial, analysis of the data are undertaken after all the queries and that sponsor is satisfied the data is accurate and complete

3.2. involvement during the pre-study phase regarding study design, sample size estimation, statistical methodology, analysis and reporting

4. Clinical Study Manager

4.1. ensure that studies are carried out according to the study protocol, SOPs, and ICH-GCP regulations and study specific manuals and procedure

4.1.1. Materials

4.1.2. Personel

4.1.3. Services

4.1.4. Duration

4.2. investigation of queries and monitoring discrepancies

4.3. management of study drug accountability

4.4. clinical data review of data listings and summary tables

4.5. tracking and reporting of study including site activation, patient enrolment

5. Research Pharmacist

5.1. Detailed instructions regarding the ordering, handling, score storage, and dispensing of the investigational agent

5.2. procedures should be developed for returning or disposing of any unused or damaged products

5.3. appropriate packing and labelling must comply with regulatory requirements

5.4. continuity in providing study sites with study drug based on the protocols

6. Data manager

6.1. study procedures, such as randomization methods, assigning of study identifiers to participants and blinding, will be determined and tested prior to the first participant enrolment

6.2. ensure that the selected data system is able to handle the data, including testing the case report forms as well as the database where the data will be stored.

6.3. if the data will be entered electronically, it is ensured that the systems that are used should control across to and manipulation of data such that: changers are made to data are documented: deletion are prevented, security of data is maintain, and integrity of trial is assured

7. Research Nurse

7.1. discussions relating to patient care

7.2. managing treatment-related side effects, quality of life issues

7.3. symptom management before, during, and after treatment