Following is a list of activities that need to be completed at each site, before the trial is launched:
- It should be ensured that the research team is identified and recruited, at each site.
- The sponsor must ensure that all required trial supplies are available at each site, which include:
- The Investigational Product (IP).
- Placebo, comparator (if applicable).
- Case Record Forms (CRFs).
- Informed Consent Documents (ICDs), which include Participant Information Sheets (PISs), Informed Consent Forms (ICFs), any other document that has been prepared to provide trial related information to the participants.
- Computers, tablets, or any other device required for data collection and entry.
- Logs and forms that have to be completed by the site staff. For example, forms for reporting Adverse Events (AE), Serious Adverse Events (SAE), etc.
- Standard Operating Procedures (SOPs) for each trial specific process, which have been approved by the sponsor and the principal investigator.
- Audio visual aids, if the consent process of the trial includes audio visual recording.
- The sponsor should ensure that the relevant agreements have been signed (Clinical Trials Agreement).
- Generally, prior to commencing the trial, the sponsor organises an Investigator’s Meeting (IM). IM is organised to train all the investigators and the lead staff on all trial related activities, to ensure that the trial is conducted in accordance to the applicable regulations, guidelines and the protocol. The meeting includes training and discussion on: the trial protocol, completion of documents (CRF, ICD and logs) and recruitment strategies. It is important to document the attendance for this meeting.
- The monitoring team must ensure that all site initiation visits have been completed, and the sites are ready for the trial to commence.
- The Trial Master File (TMF) and Investigator Site Files (ISF) should be set-up, with the essential documents filed. For example, the approval letter from Central Drugs Standard Control Organization (CDSCO), Ethics Committee approval letter, CV of the investigator, etc.
- The final approved protocol must be signed by the sponsor and all investigators. A copy of the signed protocol and the Investigator’s Brochure (IB) or the SmPC (Summary of Product Characteristics) must be available at each site, and the original copy should be filed in the TMF.
- The sites must have the required finances for the trial, as per the financial plan.