The FDA has announced that it will disclose clinical study reports (CSRs) in a pilot program from Jan.2018. Participation in the pilot is voluntary for sponsors, and limited to up to 9 recently approved new drug applications (NDA) with a focus on products that are...
FDA has updated the information sheet on payments and reimbursements to research subjects. The new sheet states that reimbursement for travel expenses is acceptable. FDA does not consider reimbursement for travel expenses to and from a trial site and associated costs (including airfare, parking and...
The Danish Medicines Agency (DMA) has published an article about whether or not FDA 1572 form should be signed by the investigators outside US in a multinational trial. According to DMA, an investigator in Denmark cannot comply with the requirements in the 1572 form, therefore the...
FDA and Office for Human Research Protections (OHRP) have relapsed final guidance that answers commonly asked questions on using electronic systems and processes to obtain informed consent. The guidance provides recommendations on the use of electronic system and processes to obtain informed consents such as graphics,...
On 2.May.2017 The National Institues of Health (NIH) and FDA Joint Leadership Council has issued a final version of the protocol template for clinical trial investigators. The NIH-FDA protocol template is primarily intended for clinical investigators who are writing protocols for phase 2 and phase 3 NIH-funded...
