The Informed Consent Process and the changes introduced to the Declaration of Helsinki in 2013. Part 3 of 5

Declaration of HelsinkiPart 3: Vulnerable Persons and Consent

Another distinctive modification in this new revision is the expansion of considerations on vulnerable populations and their needs of specifically considered protection according to the case.

With respect to the Informed Consent Process, the Declaration preserves the essential principle that Continue reading

The Informed Consent Process and the changes introduced to the Declaration of Helsinki in 2013. Part 2 of 5

Part 2: General Modifications

Declaration of HelsinkiIn the October 2013 revision, some definitions and statements that affect the informed consent process are explained in more detail which undoubtedly is a consequence of the current progresses attained in the clinical development activity.

These re-definitions in the General Principles of the Declaration are aimed to improve the Continue reading

FDA releases draft guidance to outline standardized electronic study data format

When finalized, the guidance for industry “Providing Regulatory Submissions in Electronic Format – Standardized Study Data” will specify and implement electronic submission requirements for study data contained in NDAs, ANDAs, certain BLAs, and certain INDs. This guidance’s requirements will also be applied to Continue reading

Guidance for Industry: Electronic Source Data in Clinical Investigations

In an effort to increase the reliability, quality, integrity and traceability of electronic clinical data the FDA has finalized a draft guidance (Guidance for Industry: Electronic Source Data in Clinical Investigations) released in November of 2012. “The guidance provides recommendations to sponsors, CROs, clinical investigators and others involved in the capture, review, and retention of electronic source data”. Ideally this guidance will help Continue reading