Affinity Clinical Research

Latest News and Information

GCP Thursdays: Informed Consent

When faced with treatment decisions, it is not uncommon for patients to ask "What do you think I should do?".  This is only natural - when faced with making a difficult decision, it makes sense to ask for expert advice.  And as a health professional who wants what's...

read more

GCP Thursdays: Serious v Severe AEs

There is often a lot of confusion about the difference between a severe adverse event and a serious adverse event.  Severity is a grading.  Adverse Events (AEs) can be classified as mild, moderate or severe.  An AE can be severe without being a Serious Adverse Event....

read more

GCP Thursdays: The National Statement

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...

read more

GCP Thursdays: Standard of Care

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...

read more

GCP Thursdays: eCRF

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...

read more

GCP Thursdays: Archiving

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,...

read more

Is it time for a Spring Clean?

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...

read more

GCP Thursdays: Best Interest of Patient

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...

read more

GCP Thursdays: Essential Documents

Slow study start-up times are a major problem for Sponsors running clinical trials.  The last thing a site wants to do is contribute to this problem.  By ensuring you have the correct Essential Documents on hand, you can help your site be initiated quickly. The full...

read more

GCP Thursdays: Informed Consent

When faced with treatment decisions, it is not uncommon for patients to ask "What do you think I should do?".  This is only natural - when faced with making a difficult decision, it makes sense to ask for expert advice.  And as a health professional who wants what's...

read more

GCP Thursdays: Serious v Severe AEs

There is often a lot of confusion about the difference between a severe adverse event and a serious adverse event.  Severity is a grading.  Adverse Events (AEs) can be classified as mild, moderate or severe.  An AE can be severe without being a Serious Adverse Event....

read more

GCP Thursdays: The National Statement

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...

read more

GCP Thursdays: Standard of Care

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...

read more

GCP Thursdays: eCRF

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...

read more

GCP Thursdays: Archiving

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,...

read more

Is it time for a Spring Clean?

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...

read more

GCP Thursdays: Best Interest of Patient

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...

read more

GCP Thursdays: Essential Documents

Slow study start-up times are a major problem for Sponsors running clinical trials.  The last thing a site wants to do is contribute to this problem.  By ensuring you have the correct Essential Documents on hand, you can help your site be initiated quickly. The full...

read more