For PMS study, the investigator of a hospital plans to perform a procedure at another branch of the same hospital in a different state as the patient is not able to travel to the primary site. What are important ethical considerations for this situation?
Gajjela Praveen
There is an FDA guidance “Use of Investigational Products When Subjects Enter a Second Institution” (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-investigational-products-when-subjects-enter-second-institution).
This situation is relevant to a multi-centric-trial in which a patient, who is enrolled at a site in a city (site 1) where he finds it inconvenient to follow up a site in his own city (site 2). The EC of the site 1 is responsible for overseeing the safety and well-being of the patient. If the patient is transferred to site 2 you will need to obtain approval of the ECs of both the sites. This process is likely to take quite some time as the ECs usually meet as per their schedule. Also, EC of second site can give approval/no objection only after reviewing the protocol and ICF This means that the patient must continue the follow up visits at site 1 till both ECs have given their agreement/approval. There would be also issue of obtaining the patient’s consent again at site 2.
There is a US FDA warning letter (Sep 27, 2000) issued to an investigator for not reporting to EC of second site and getting approval. If this procedure of only for 1 patient, it could be considered a protocol deviation, which would require notification to the EC and the sponsor. If this practice is to be followed for many patients because of convenient of site proximity, you will have to amend the protocol and obtain EC approval from both the sites and notify Central Drugs Standard Control Organisation (CDSCO).
Pl also consider other important issues informed consent, safety reporting, medical management, CRF completion, source document/data, and monitoring.
What is the literacy level requirement for informed consent process?
Ajay Desai
Larson’s 2015 review revealed that most ICFs were written at a 10th grade reading level or higher across all medical specialties.
However. most researchers (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5915809/) recommend that informed consent forms (ICF) should be written at a sixth to eighth grade reading level or lower.
Is it mandatory to provide patient data in registry?
Mala Ramakrishnan
In US, FDAAA 801 and the Final Rule 2007 require submission of results in a registry. In India, there is no such requirement.
What are regulatory requirements for non-intervention studies (NIS) in India?
Dr Radha Bhide
As per New Drugs and Clinical Trials Rules for post marketing surveillance study or observational or non-interventional study for active surveillance, protocol for non-interventional study for active surveillance requires CDSCO approval of is necessary. For other non-interventional study, Central Drugs Standard Control Organisation approval of protocol is not necessary.
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