Approval of the study protocol will normally apply to investigator-led studies where the sponsor is either providing the intervention for free, or funding the study. In this case, the investigator will be obligated to submit not just the protocol but any amendments, as well as planned publication to the sponsor for approval. In addition, the sponsor may require an ongoing update at agreed intervals - usually annually to monitor trial progress.
In studies where the sponsor is funding and running the trial, they will usually have an internal approval process to ensure that the protocol is critiqued by an independent team of trial professionals including statisticians, medics, regulatory and the clinical operations team. The internal approval process will vary from company to company but the main aim will be to ensure that the protocol is robust and will achieve the objectives of the study and also to obtain cross functional agreement in terms of funding and resources required to conduct the study. For either processes, sponsor approval will need to be in place prior to any necessary submissions.
A useful resource for this section is the Regulatory Database http://regulatory.ghtcoalition.org/
Clinical Research Governance Office, Imperial college London “what is a Sponsor”
For a clinical trial to comply with GCP it must have a Sponsor. There are various types of Sponsor which will be applicable depending on the nature of your ...
Creating a trial protocol
Creating a Trial Protocol can be very daunting but is the most important planning stage of the trial. This can be a lengthy process so try ...
I would want colleagues to share their experience on situations where an investigator has stopped as study procedure due to safety concerns before communicating to IRBs and Regulatory Agencies
Published in January 2013 in both the BMJ and Annals of Internal Medicine, the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) 2013 Statement provides guidance regarding the minimum content ...
i³ is delighted to announce that as part of our ongoing commitment to supporting the impact of research internationally, we are offering a full fees paid place at the 2015 ...
The educational program titled "Clinical Drug Development Process: ICH Good Clinical Practice for Clinical Trial Sites is sponsored by Quintiles Transnational.
This program is intended for ...