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Becoming an investigator

Guidelines for Becoming a Clinical Study Investigator

The following highlights the key responsibilities of a Clinical Study Investigator.

Qualifications

The Clinical Study Investigator should:

  • Be qualified to practice medicine or psychiatry and meet the qualifications specified by applicable national regulatory requirements(s)
  • Be qualified by education, training, and experience to assume responsibility for the proper conduct of the study,
  • Be familiar with and compliant with Good Clinical Practice (GCP) ICH E6 Guideline and applicable ethical and regulatory requirements prior to commencement of work on the study. Please complete the GCP Investigator e-learning to get a certificate and be able to provide this upon request.
  • Provide evidence of his/her qualification using the Abbreviated  TransCelerate Curriculum Vitae (CV) form available on the  following link: TransCelerate Curriculum Vitae Form

Study Preparation

The Clinical Study Investigator should:

  • Be thoroughly familiar with the appropriate use of the investigational product(s) as described in
    • The clinical study protocol
    • The Investigator’s Brochure and/or Product Information
    • Other relevant information
  • Be able to recruit suitable patients within the agreed recruitment period.
  • Have available an adequate number of qualified staff for the duration of the study to conduct the study properly and safely.
  • Conduct the research at a facility that is properly equipped based upon the needs of the study protocol. Examples of items in a properly equipped site include but are not limited to, drug storage location, availability and access to a computer, laboratory sample collection and preparation for shipment, etc.
  • Ensure that all staff assisting with the study are adequately informed about the protocol, the investigational product(s), and trained for their study-related duties and functions.

Patient Safety

The Investigator must:

  • Exhibit the highest ethical standards
  • Prioritise patient safety and well being
  • Ensure that the benefits and risks of participating in a study are explained and understood by the patient, based on an assessment of available evidence.

Study Conduct

The Investigator must:

  • Conduct the study in compliance with Good Clinical Practice (GCP), the ethical principles contained in the Declaration of Helsinki and applicable national ethical and regulatory requirements
  • Obtain voluntary informed consent from each patient prior to his participation in the clinical study. Please complete the innovative and interactive e-learning ‘Informed Consent – Improving patients’ experience’ to increase your understanding of ethical and practical aspects related to informed consent process
  • Conduct the study in compliance with the clinical study protocol and ensure that staff and patients follow all required procedures
  • Ensure the accuracy and timeliness of the data reported to AstraZeneca
  • Permit and be present at the regular site visits where AstraZeneca monitors verify study data and review the progress and conduct of the study.
  • Securely maintain the study documents and clinical supplies as agreed with AstraZeneca.

Being considered for a study:

  • When the Investigator’s site is being considered for a clinical study, a representative of AstraZeneca will evaluate whether the site is appropriate for the study during a Pre-study visit. To submit a request to become a Clinical Trial Investigator click here
  • If the site is deemed suitable for study participation, the AstraZeneca representative(s) will work with the Investigator to review agreements, documentation and training required to participate in the study.
  • The investigator will be requested to sign a confidentiality agreement.

Starting the study

  • Investigator Meetings: Investigators and other site staff may be invited to participate in an investigator meeting to review study details. The meeting format may be face-to-face (sometimes conducted during weekends) or web-based (usually conducted during regular working hours).
  • Site Initiation Visit: A clinical study monitor representing AstraZeneca will visit the site and meet with the Investigator and the study site staff to ensure the site’s readiness and to prepare for patient enrollment.

Enrolling patients:

The Investigator is responsible for the following activities:

  • Ensure the enrollment of a pre-determined number of patients who meet study criteria.
  • Ensure all advertisements are approved by the Ethics Committee or IRB and AstraZeneca prior to using them
  • Demonstrate due diligence to ensure patient compliance with study procedures and schedule of assessments.

Next Steps:

  • Review and become knowledgeable of the ICH E6 Guideline
  • Take an approved Clinical Research Training course such as the one offered through the DIA