Affinity Clinical Research

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...

We all know that Informed Consent must be performed by an Investigator but does this stop other staff members from participating the informed consent process? No.  In fact, I encourage all study coordinators to be involved in the informed consent process. ...

There is nothing like the word "budget" to strike fear into the heart of a health professional.  As I explained in Part 1 of this series, there is no need for research budgets to be a scary exercise.  Once you have the Patient Payment down, the rest is easy peasy. ...

What do you do if a study procedure is in the HREC approved protocol but not in the HREC approved Informed consent form?  You may think this will never happen but this is a real life scenario. We all know to comply with GCP no study procedures can be performed without...

It amazes me how many clinical sites struggle with clinical research budgets.  Perhaps I shouldn't be so surprised - after all, researchers are typically people whose passion is science and humanities rather than accounting and business.  However, to be sustainable,...

At Affinity we know that HREC submissions can be stressful.  The pressure of submission deadlines combined with managing a busy clinic means that submissions are often rushed or costly overtime is needed. Affinity can take the pressure off and free up your staff for...

Identifying an adverse event (AE) can be tricky for those new to research (and even sometimes for experienced researchers).  It is easy to confuse the terms "adverse event" and "side effect" but in research these have very different meanings.  An AE is defined as "any...

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...

We all know that Informed Consent must be performed by an Investigator but does this stop other staff members from participating the informed consent process? No.  In fact, I encourage all study coordinators to be involved in the informed consent process. ...

There is nothing like the word "budget" to strike fear into the heart of a health professional.  As I explained in Part 1 of this series, there is no need for research budgets to be a scary exercise.  Once you have the Patient Payment down, the rest is easy peasy. ...

What do you do if a study procedure is in the HREC approved protocol but not in the HREC approved Informed consent form?  You may think this will never happen but this is a real life scenario. We all know to comply with GCP no study procedures can be performed without...

It amazes me how many clinical sites struggle with clinical research budgets.  Perhaps I shouldn't be so surprised - after all, researchers are typically people whose passion is science and humanities rather than accounting and business.  However, to be sustainable,...

At Affinity we know that HREC submissions can be stressful.  The pressure of submission deadlines combined with managing a busy clinic means that submissions are often rushed or costly overtime is needed. Affinity can take the pressure off and free up your staff for...

Identifying an adverse event (AE) can be tricky for those new to research (and even sometimes for experienced researchers).  It is easy to confuse the terms "adverse event" and "side effect" but in research these have very different meanings.  An AE is defined as "any...