1 Maintaining Adequate Resources:
o Ensure that required number of suitable subjects is recruited within the agreed recruitment period.
o Provide sufficient time to properly conduct and complete the study within the agreed study period.
o Ensure availability of adequate number of qualified staff and adequate facilities for the conduct the study properly and safely.
2 Protocol, Informed Consent Form (ICF), Case Report Form (CRF), SOP Preparation:
o Coordinate with the clinical research personnel for preparation of the SOP.
o Coordinate with the Clinical Research personnel for preparation of Protocol, ICF and CRF.
3 Medical Care of Study Subjects:
o Ensuring adequate medical care for the subjects in the study for any adverse events, including clinically significant laboratory values, related to the study.
4 Communication with IEC:
o To obtain written and dated approval/favorable opinion from the IEC for the study protocol, informed consent form, and any other written information to be provided to subjects.
o Incorporate the suggestion given by IEC members in respective documents and take re-approval in case of any changes.
o Should provide the IEC with a current copy of the Investigator's Brochure. If the Investigator's Brochure is updated during the study, the copy of the updated Investigators Brochure should be provided.
o Inform any amendment regarding the Protocol, ICF and safety related information, Clinical updates to IEC, Sponsor and applicable regulatory authorities.
5 Compliance with Protocol:
o Ensure that the study is conducted in compliance with the protocol agreed by the sponsor and, if required, by the regulatory authority and which was given approval/favorable opinion by the IEC.
o Ensure that no deviation from, or changes in the protocol is made without agreement by the sponsor and prior review and documented approval/favorable opinion from the IEC, except where necessary to eliminate an immediate hazard to study subjects, or when the change involves only logistical or administrative aspects of the study.
o Ensure proper documentation of any deviation from the approved protocol.
6 Investigational Product:
o Literature survey of clinical and non clinical information regarding Investigational Product.
o Review of Investigators Brochure for NCE studies.
o Ensure maintenance of accountability of investigational products.
o Ensure maintenance of records of the product's delivery to the study site, the inventory at the site, the use by each subject, and the return to the sponsor or alternative disposition of unused product.
o Ensure maintenance of document regarding subjects dosing specified by the protocol and reconcile all investigational product received from the sponsor.
o Ensure that all investigational products should be stored as specified by the sponsor and in accordance with applicable regulatory requirement.
o Ensure that the investigational product is used only in accordance with the approved protocol.
o Ensure proper dispensing and dosing of investigational product as per protocol.
7 Randomization Procedures and Unblinding:
o Ensure that randomization procedures are followed and should ensure that the code is broken only in accordance with the protocol.
o Promptly document and explain to the sponsor any premature unblinding of the investigational product in case of blinded study.
8 Informed Consent of Study Subjects:
o Ensure that the Activities of ICD Presentation, Obtaining written Informed consent and documenting informed consent process comply with the applicable regulatory requirements and GCP and to the ethical principles that have their origin in the Declaration of Helsinki.
o Ensure revision of written informed consent form when any important new information becomes available that may be relevant to the subjects consent.
o Ensure that there is no coerce or unduly influence on subject to participate or to continue his/her participation in a study.
o Ensure that all pertinent aspects of the study including the information and the approval/ favorable opinion by the IEC should be fully informed to the subject or, if the subject is unable to provide informed consent, the subject's legally acceptable representative.
o Ensure that prior to a subjects participation in the trial, the informed consent form should be signed and personally dated by the subject or by the subject's legally acceptable representative, and by the study site personnel
o Ensure that the subject or the subject's legally acceptable representative should receive a copy of the signed and dated written informed consent form.
9 Study Related:
o Coordinate with the clinical research personnel for planning of study schedule.
o Provide protocol training and delegate the duties to study personnel on the basis of their competency level.
o Ensure that all the volunteers reported for ICF presentation are fit for participation in the study as per the respective protocol.
o Ensure proper handling and reporting of Adverse Events/Serious Adverse Events and Adverse Drug Reactions and Clinical emergencies.
o Supervision of Dosing.
o Guide the nursing staff in maintenance of emergency medicines and Special Care Room.
o Monitor the study and ensure that the study is conducted as per approved Protocol, International Conference on Harmonization-Good Clinical Practice (ICH-GCP), and applicable regulatory and in house Standard Operating Procedures (SOP).
o Generation and maintenance of Essential documents pertaining to a study.
o Handling of QA findings and Compliance check procedure
o Handling sponsor or study related regulatory audits.
o Surprise visits to clinics during nights are being made to ensure that designated study personnel are on job in the clinics.
10 Progress Reports:
o Ensure that written summaries of the study status is submitted to the IEC annually, or more frequently, if requested by the IEC.
11 Safety Reporting:
o Ensure that all serious adverse events (SAEs) should be reported immediately to the sponsor and IEC. The immediate reports should be followed promptly by detailed, written reports.
o Ensure compliance with the applicable regulatory requirement related to the reporting of unexpected serious adverse drug reactions to the regulatory authority, sponsor and the IEC.
12 Premature Termination or Suspension of a Study:
o Ensure that in case of the premature termination or suspension of study, the same should be promptly informed to the study subjects/sponsor/applicable regulatory/IEC and appropriate therapy and follow-up for the subjects should be provided.
13 Report Preparation:
o Co-ordinate for the study report preparation with Report writer and Project manager
o Ensure that upon completion of the study, IEC is provided with a summary of the studys outcome, and the regulatory authority with any reports required.
o Ensure that all study related documents are archived in compliance with the applicable SOPs or as per applicable regulatory guideline.