Objectives: Before executing a clinical trial there is a lot of administrative work to do. The initiator of the study has to ask for and create several essential documents such as contracts, study protocol and case report form to name but a few. The aim of this research was to identify the current main challenges and time consumption during this planning phase of an investigator initiated trial...

BACKGROUND It is difficult to implement change in general practice. It is not known how best to conduct effective continuing medical education in general practice. General practitioners' criteria for good clinical practice vary and it is unknown whether systematic education by hospital specialists could be expected to reduce variation between general practitioners. AIM A study was undertaken ...

Clinical trials are emerging as an important activity in India as it is an essential component of the drug discovery and development program to which India is committed. The only robust way to evaluate a new medicine is by doing properly designed clinical trials. In addition to advancing science, clinical trials offer myriad benefits to the participants. The recent hue that created in India abo...

Good clinical practice (GCP) guidelines should always be implemented and obeyed in clinical interventional studies. In this mini-review, we will address several burning questions relating to GCP in a concise 'frequently asked questions' format. While compliance to current rules and regulations is our mission, we also wish to play devil's advocate attempting to translate the rules into sizeable ...

BACKGROUND Recruitment to randomised controlled trials with children is challenging. It is imperative to understand the factors that boost or hinder recruitment of children to clinical trials. We conducted a survey of facilitators and barriers to recruitment to the MAGNETIC trial, using a previously developed web-based tool. METHODS MAGNETIC is a multicentre randomised trial of nebulised magn...

The analytical characterization and testing of peptides manufactured as active pharmaceutical ingredients according to GMP (Good Manufacturing Practice) is discussed. In particular, recommended methods and specifications for identity, purity and content are addressed.