You want to keep your trial on track, but physical distancing and travel restrictions have made it difficult. Fortunately, IMARC has experience providing remote services.
ICH GCP E6 4.8.3 states that neither the investigator, nor the trial staff, should coerce or unduly influence a subject to participate in a trial, and special care must be taken to assure it is met when dealing with populations whose very nature places them in a situation where they might be more easily coerced or influenced.
Topics: Children, Assenting, 45 CFR 46, FDA, Clinical Research
ICH GCP E6 4.8.3 states that neither the investigator, nor the trial staff, should coerce or unduly influence a subject to participate in a trial, and special care must be taken to assure it is met when dealing with populations whose very nature places them in a situation where they might be more easily coerced or influenced.
Topics: Children in Clinical Research, Assent, ICH GCP E6 4.8.3, 45 CFR 46