Quality and Informed Consent Procedures

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1 Quality and Informed Consent Procedures.

2 GZA hospitals is a member of Iridium Cancer Network Partner Hospitals Iridium Cancer network: GZA ziekenhuizen AZ KLINA AZ Nikolaas AZ Monica AZ Sint-Jozef Malle UZA ZNA (2016) 2

3

4 Introduction: Informed Consent Made by the sponsor LEC and nonlec s can ask for changes. Many years ago: Priority to inform the patient on the essentials of study Limited in size and content Currently: It is a booklet with detailed and sometimes difficult information It has different parts ; screening, participation, optional biopsies, sending and reclaiming of archived tissue, optional genetic analysis, pharmacokinetics,. It is both a legal document and an information document. This has implications for the language used 4

5 Introduction: Informed Consent Difficulties to discuss this IC with the Oncological Patient Many patients don t know anything about the different kind of therapies Diagnosis of PD full of emotions feel time pressure At this moment: how many patients will can read and understand an IC withouth some additional help/guidance? = TIME It is the mission of every trial office to combine The patients interest Ascertain the understanding of the IC document Guide them through this without inappropriate interfering with free choice The perform this within GCP boundaries How do we deal with it at CTO? 5

6 6 History: IC procedures

7 7

8 8 Flow chart of core process

9 Flow chart core process CTO Phase I: Design (internal or external) Phase II: Intake Design new study Phase IV: Execution Open for inclusion Recruitment Patient process Proposal new study to BC Yes Informed Consent No Stop Approval BC No Yes Yes Screening No Financial approval No Stop Yes Inclusion Yes Approval EC No Active therapy Yes Phase III: Preparation Follow-up Drafting and signing contract Phase V: Completion Initiation visit Closing for inclusion Administrative start of study Final closing 9 Open for inclusion Archiving

10 Patient process Recruitment Informed Consent Screening Inclusion Active therapy: Follow-up End of study According to IC procedure Including randomisation Patient visits Active follow-up Safety follow-up Survival follow-up Visit process Planning Execution CRF Monitoring Billing Payment collection 10

11 11 Informed consent procedure

12 Documents: IC procedure a. IC roadmap b. Financial template c. GZA portaal (electronic portal) 12

13 Responsibilities prescribed in the IC Principal and subinvestigator: Correct use of the procedure and working conform ICH/ GCP Studycoördinator: Conform ICH/GCP Responsible for support of the doctor Control and follow up of the IC procedure. Responsible for the most recent version of the IC on our electronic platform. 13

14 General rules ICH/GCP conform Only principal and sub investigator listed on the delegation log can include and see studypatients All other doctors: has to refer potential study patients to PI or sub investigators ICH/GCP compliance Documentation in electronic patient source: potential candidate decision of participation decision of withdrawal EOT every deviation on IC procedure 14

15 15

16 16 a. Informed consent roadmap

17 17

18 18

19 19

20 b. Informed consent financial template 20

21 Financial template Law 10/ 05/2014 The doctor has to document in the medical file of the patient what is SOC and what is no SOC. It has an impact during contract negotiation Contract IC Financial template New trend in IC to explain what is SOC Sometimes this is against the SOC of a center 21

22 22

23 23

24 24 GZA Portaal

25 Practical issues at CTO IC is a booklet Will every patient read a main IC of 20/ 30 pages + IC PG +IC? It takes a lot of time and effort from the doctor and the study nurse to discuss with the study patient to make sure the patient understand the IC The whole proces with all docs and notes takes hours from the whole studyteam/ most of the time no efficient financial compensation foreseen Major protocol deviation Wrong date Signed but no written name Different dates Patient forgot to tick a box 25

26 Practical issues What about the many amendments? How to manage them: Many patients in a trial Many amendements on the IC (7/8) No highlighted sections in the new IC Important we are immediately informed about every submission of an IC amendments Impact on Contract Financial template Sponsors ask we deliver quality but this takes time 26

27 27 Thank you

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