The Ministry of Health and Family Welfare in India has issued the draft Clinical Trials Rules 2018. It applies to all new drugs, investigational new drugs for human use, clinical trial, bioequivalence study, bioavailability study and Ethics Committee. It will come into force after its...
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 use of e-TMFs and electronic archiving generally requires the digitisation of paper records to generate electronic copies of the documents. When original paper TMF documents are transferred to an electronic format (digitsation), the process of transfer should be validated in order to ensure that...
According to the European Commission CT-3: “Detailed guidance on the collection, verification and presentation of adverse event/reaction reports arising from clinical trials on medicinal products for human use”: The sponsor must ensure that all SUSARs are reported to the authorities as soon as possible; within seven...
According to GCP addendum 4.2.5: The investigator is responsible for supervising any individual or party to whom the investigator delegates trial-related duties and functions conducted at the trial site. The question is: How to define an adequate oversight/supervision by the investigator? When the investigator has agreed to...
There is a clear description in GCP regarding requirement for accountability of investigational medicinal products such as: 4.6.1: Responsibility for investigational product(s) accountability at the trial site(s) rests with the investigator/institution. 4.6.3 The investigator/institution and/or a pharmacist or other appropriate individual, who is designated by the investigator/institution,...
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...
One of the most frequent critical GCP findings is when the in-/exclusion criteria were not followed. Often, the screening period varies several days in order to complete all the screening tests. Even the investigator is convinced of the subject’s suitability, the investigator should wait with...
European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance on 22.Nov.2017. EudraVigilance is the European system for monitoring the safety of medicines. It facilitates electronic reporting of suspected adverse reactions related to medicines and the effective analysis of data. This enables the...
