Affinity Clinical Research

If you have read the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA comments, you would be aware that Section 3 - Institutional Review Board/Independent Ethics Committee is not included.  This is because the TGA has adopted the...

If someone is performing a Standard of Care procedure for a trial patient, do they need to be on the delegation log?  If the "Standard of Care" procedure does not form part of the trial, the answer is "no" and the procedure becomes part of the patient's...

The electronic case report form (also called electronic data capture or EDC) is a staple of modern day clinical research.  The eCRF has replaced the paper CRF is many studies it is more efficient and more cost effective. Just as the investigator signs the paper CRFs...

For trials conducted in Australia, the TGA requires that Essential Documents for a clinical trials are kept for a minimum of 15 years after the completion of the study.  It is impractical to retain records in the research clinic for such a length of time and,...

Spring is finally here!  It is a wonderful feeling to throw open the windows and doors, let the fresh air in and clear out some of those cobwebs (both literally and figuratively).  The arrival of Spring has got me thinking it must be time for the annual cleanout and...

It is not uncommon for Investigators to find themselves in the position of having to decide whether following the protocol is in the best interest of the patient.  Sometimes it is clear cut but other times, it is more difficult and involves weighing up the benefits...

It is true that most people did not get involved in research because of their love of business and accounting.  Unfortunately, it is important as a Manager of a Research Unit to have a handle on the accounts in order to be sustainable.  Whether your research unit is...

Why do I have to fill out training logs every time there is a Protocol Amendment?  The answer is that you don't. GCP Section 4.2.4 requires "all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their...

If you have read the Note for Guidance on Good Clinical Practice (CPMP/ICH/135/95) - Annotated with TGA comments, you would be aware that Section 3 - Institutional Review Board/Independent Ethics Committee is not included.  This is because the TGA has adopted the...

If someone is performing a Standard of Care procedure for a trial patient, do they need to be on the delegation log?  If the "Standard of Care" procedure does not form part of the trial, the answer is "no" and the procedure becomes part of the patient's...

The electronic case report form (also called electronic data capture or EDC) is a staple of modern day clinical research.  The eCRF has replaced the paper CRF is many studies it is more efficient and more cost effective. Just as the investigator signs the paper CRFs...

For trials conducted in Australia, the TGA requires that Essential Documents for a clinical trials are kept for a minimum of 15 years after the completion of the study.  It is impractical to retain records in the research clinic for such a length of time and,...

Spring is finally here!  It is a wonderful feeling to throw open the windows and doors, let the fresh air in and clear out some of those cobwebs (both literally and figuratively).  The arrival of Spring has got me thinking it must be time for the annual cleanout and...

It is not uncommon for Investigators to find themselves in the position of having to decide whether following the protocol is in the best interest of the patient.  Sometimes it is clear cut but other times, it is more difficult and involves weighing up the benefits...

It is true that most people did not get involved in research because of their love of business and accounting.  Unfortunately, it is important as a Manager of a Research Unit to have a handle on the accounts in order to be sustainable.  Whether your research unit is...

Why do I have to fill out training logs every time there is a Protocol Amendment?  The answer is that you don't. GCP Section 4.2.4 requires "all persons assisting with the trial are adequately informed about the protocol, the investigational product(s), and their...