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Affinity Clinical Research

Latest News and Information

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

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: Amendment Training

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...

read more

GCP Thursdays: Protocol Deviations

When is a Protocol Deviation not a Protocol Deviation?  GCP clearly states that all research must be completed as stated in the protocol otherwise it is a deviation and must be reported to the Sponsor and HREC.  But what if the site feels they have followed 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

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: Amendment Training

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...

read more

GCP Thursdays: Protocol Deviations

When is a Protocol Deviation not a Protocol Deviation?  GCP clearly states that all research must be completed as stated in the protocol otherwise it is a deviation and must be reported to the Sponsor and HREC.  But what if the site feels they have followed the...

read more