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Affinity Clinical Research

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GCP Thursdays: Informed Consent

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. ...

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GCP Thursdays: 

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...

read more
GCP Thursdays – Grading an Adverse Event

GCP Thursdays – Grading an Adverse Event

Grading of an Adverse Event (AE) is ultimately the responsibility of the Investigator.  Each protocol will have slightly different requirements and use different grading systems.  By being familiar with the different grading systems, Study Coordinators can assist the...

read more

Limited Time Offer on HREC submissions

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...

read more

GCP Thursdays – Adverse Events

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...

read more
GCP Thursdays

GCP Thursdays

Follow us on Facebook to receive Good Clinical Practice (GCP) tips every Thursday.  Written for Study Coordinators by a Study Coordinator, these tips are practical, relevant and guaranteed not to put you to sleep (unlike the IM training).

read more

GCP Thursdays: Informed Consent

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. ...

read more

GCP Thursdays: 

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...

read more
GCP Thursdays – Grading an Adverse Event

GCP Thursdays – Grading an Adverse Event

Grading of an Adverse Event (AE) is ultimately the responsibility of the Investigator.  Each protocol will have slightly different requirements and use different grading systems.  By being familiar with the different grading systems, Study Coordinators can assist the...

read more

Limited Time Offer on HREC submissions

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...

read more

GCP Thursdays – Adverse Events

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...

read more
GCP Thursdays

GCP Thursdays

Follow us on Facebook to receive Good Clinical Practice (GCP) tips every Thursday.  Written for Study Coordinators by a Study Coordinator, these tips are practical, relevant and guaranteed not to put you to sleep (unlike the IM training).

read more