Flinders University receives funding for PaCCSC from the Australian Government Department of Health and Ageing under the National Palliative Care Program.

Monitoring PaCCSC studiesImproving quality

Acknowledgements Each and every site

– Investigators– Site coordinators– Study staff

Caroline Litster, Natalie Cutri, Linda Devilee

Brief overview PaCCSC has a comprehensive

monitoring programme– Unusual for investigator initiated studies– Usual for pharmaceutical sponsored studies– Programme is based on best practice and

ICH GCP guidelines• All sites• All participants

– Incorporates an element of pragmatism and realistic opportunity

Monitoring GCP requirement of sponsors Verifies

– rights and well being of participants– protocol has been followed– trial conduct is in compliance with GCP

Also a means to verify participant data– Data used in the study analysis is correct and can

be verified from other sources– The study results are based on the data from

participants– ensures that participant data counts

Monitoring Is a detailed review of study documents,

protocol implementation and procedures– After study is complete this is the only way to

verify compliance Enables assessment of each site and the

opportunity to provide support for specific problems

Enables training at each site to bring about internal quality improvement

Monitoring Assess all site files Review all participant files against source

documents Targeted review of critical data elements

– Eligibility– Consent– Administration of study medication– Review of safety assessments– Review of primary outcome assessments– Reasons for cessation

What worked well Early monitoring included a variety of

strategies– Aimed at simply getting through the numbers

of files required– Also to increase learning amongst sites and

to increase the capacity of all in a period of learning and expansion

– Fostered mentoring between recruitment sites and with PaCCSC

Ketamine study Monitoring included taking a site

coordinator to monitor another site along side the PaCCSC monitor

Rotated at least once On site training

Ketamine study Enabled each site coordinator to see how

another site organised their files, how they prepared for monitoring, and what problems arose

Site coordinators could discuss recruitment, filing, organisation and staffing issues

Good feedback, and some sites implemented some of the tips seen at the other site

Ketamine study Did this process bring about

improvements in basic monitoring outcomes for this or future studies

The main problems for this study– First study and everyone was learning– Changes in HREC organisation occurred

Octreotide study Impending study closure initiated a

different monitoring strategy– All study nurses joined a teleconference to

review and discuss the specific monitoring needs for this study

– Details of monitoring process, paperwork and assessment was discussed

– Each study nurse then monitored another site alongside a PaCCSC monitor

Octreotide study Study nurses could see for themselves

what was monitored, how files at other sites looked, and what problems were found

Provided an opportunity to prepare their own files for subsequent monitoring.

Octreotide study Did this process bring about

improvements in basic monitoring outcomes for this or future studies

The main problems for this study– Study was nearing completion and findings

could not be implemented at sites for subsequent participants

Risperidone study Specific issues related to consent and

medication dosing Monitoring has been later than other

studies so lessons learned from earlier should be seen here

What didn’t work well Organisational factors

– Very difficult to arrange dates and sites availability• PaCCSC monitors• Site to be monitored• Site providing support monitor

Personnel factors– Much time taken up with training on site,

slows down the process– In some cases, networking, discussion and

learning resulted in slow file review.

Results Did any of these activities result in

improvement in monitoring outcomes at sites?

Three studies were examined– Ketamine, inpatient study, complete– Octreotide, inpatient study, complete– Risperidone, inpatient study, almost complete

General methods Reviewed all the corrective action sheets

– Listed the number of actions for each participant at each visit, along with date of randomisation

– Listed the number of actions related to general site investigator files

– Noted the dates of any training (during ketamine, octreotide, or due to previous monitoring)

– Determined the average number of errors for before training and after training.

Results

A B C D E F G H I0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

Ketamine study

Average errors prior to training Average errors post any training

Only 1 participant prior to training

Only 1 participant after training

Results

A B C D E F G H I J K L0.00

1.00

2.00

3.00

4.00

5.00

6.00

7.00

Octreotide study

Average errors prior to training Average errors post any training

Only 1 participant prior to training Did not have

training

Results

A B C D E F G H I J0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

Risperidone study

Average errors prior to training Average errors post any training

No errors in early monitoring

Only 1 participant after training

Next time Reinforce that monitoring is a QA activity

– Results from one visit should be corrected:• For the reviewed file• For next files and future files• For monitored study and other studies

Recognise that sites value visits to other sites– to compare notes and see what they are

doing– How can we continue to learn and share

experiences

Next time There are common errors across all

studies, and errors specific to a particular study– We need to identify the common errors and

determine ways to improve• Consent

– Signing, filing, documentation• Documentation• Completion of the CRFs

– Answer every question• Ensuring that source documents are clear and

available

Next time Each site needs to discuss the

monitoring outcomes between themselves– Look at the corrective actions– How could this have been avoided– What can be improved for next time and not

repeat the same errors What can PaCCSC do to assist?