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Affinity Clinical Research

Latest News and Information

International Clinical Trials Day 2017

Today we celebrate International Clinical Trials Day.  We would like to take this opportunity to thank all our volunteers, patients, trial participants and their families.  Without you, our wonderful researchers could not be doing the work that they do. Thank you also...

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International Clinical Trials Day – 20th May

On the 20th May 1747 James Lind began his trials into the cause of scurvy.  Lind's trial is recognised as one of the first clinical experiments in the history of medicine. Every year on the 20th May we pause to commemorate the work of James Lind and the countless...

read more

Happy Birthday to Us!

Today is our official first birthday and I am very excited to celebrate this milestone.  In the last twelve months, Affinity has achieved more than I could have hoped for.  Our goal at the beginning of the year was to find and initiate one study with maybe a second in...

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

International Clinical Trials Day 2017

Today we celebrate International Clinical Trials Day.  We would like to take this opportunity to thank all our volunteers, patients, trial participants and their families.  Without you, our wonderful researchers could not be doing the work that they do. Thank you also...

read more

International Clinical Trials Day – 20th May

On the 20th May 1747 James Lind began his trials into the cause of scurvy.  Lind's trial is recognised as one of the first clinical experiments in the history of medicine. Every year on the 20th May we pause to commemorate the work of James Lind and the countless...

read more

Happy Birthday to Us!

Today is our official first birthday and I am very excited to celebrate this milestone.  In the last twelve months, Affinity has achieved more than I could have hoped for.  Our goal at the beginning of the year was to find and initiate one study with maybe a second in...

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