SOP for Participant Care and Related Activities

Patient Recruitment

• Identify potential recruitment methods or strategies related to each area of the recruitment process. Obtain IEC approval of recruitment methods and materials.
• PI should start pre-screening patients as soon as required approvals are obtained so that recruitment can be started as soon as the site initiation visit is done.
• The patient will be pre-screened from the hospital database (if maintained by PI) or referred patients. As per hospital policy, there is no record maintained for the outpatient department patients. Records are maintained in the medical record department only for the inpatient department.
• PI to motivate staff to maintain an acceptable level of recruitment effort for the duration of the study (e.g. provide training or information sessions about study protocol).
• Modify the recruitment plan/strategy as necessary.

Patient Registration for Clinical Drug Trial

• The PI or designated personnel will make sure that the participant also gets registered for all visits (visits as mentioned in the protocol) as per the registration procedure of the institute.
• The study team would instruct participants to get registered with the hospital registration system for all hospital visits.
• Participant registration doesn’t mean PI has examined the participant but only informs that the participant has visited the hospital.

Participant Care before the Start of the study

• PI or designated person will examine and investigate the participant to conclude the diagnosis of the patient and also shall ensure consistency in the documentation across all relevant subject records.
• If the participant has any general practitioner, he or she shall be informed regarding the subject’s participation in the trial (if the patient permits to do so). This discussion with the general practitioner shall be documented.
• PI or designated person would note down thorough past and present medical history on hospital progress record sheets. All medications, including their dose, route, etc., will be recorded.
• All the participants previous medical records will be collected, photocopied, and maintained in the subjects’s source records. All photocopy medical records should be authenticated by PI or designated person by signing and dating.
• Participants will be given contact details for all study teams, and contact details and correspondence addresses will be obtained from the participants.

Participant care during the course of the study

• The study co-ordinator shall call the subject and schedule the visit in accordance with the protocol. This should be documented in the source notes.
• The principal investigator and qualified designated person should do the clinical examination on regular intervals irrespective of the protocol-specified procedures.
• The study coordinator would interview the patient regarding AE for all visits, and the same would be documented in source notes.
• All the study procedures are to be performed as per the protocol.
• The participant’s travel expense shall be reimbursed in total.

Participant care at the end of the study

• All the follow-up procedures are to be performed as specified in the protocol.
• PI or designated person shall inform the participant's general practitioner of the participant regarding the end of the trial.
• The participant shall be followed up for atleast one month post the final visit, irrespective of the timelines specified in the protocol. Details of these visits shall be documented in source notes.

Lost To Follow-up

• If a participant doesn’t turn up for a scheduled visit the site shall make all the efforts (at least 7 unsuccessful telephone contacts and 1 written correspondence) to contact the participant before considering the participant as lost to follow-up. All these efforts to contact the participant shall be documented in the source notes.
• For screen failure participants, the PI shall ensure the regular standard of care as per the hospital guidelines.

ALSO READ: SOP for the Active Pharmacovigilance Plan (Receipt, Handling, Evaluation & Reporting of Adverse Events.)