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Good Clinical Practice & Monitoring activities for the Roche Diagnostics dataset of the OPTIMIST trial 12-Dec-2012.

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Presentation on theme: "Good Clinical Practice & Monitoring activities for the Roche Diagnostics dataset of the OPTIMIST trial 12-Dec-2012."— Presentation transcript:

1 Good Clinical Practice & Monitoring activities for the Roche Diagnostics dataset of the OPTIMIST trial 12-Dec-2012

2 Contents 2 Julius Clinical Good Clinical Practice Informed Consent Procedure Data collection and Source Data basic requirements Noncompliance Drug Safety Basic requirements investigator Essential Documenten Amendments Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial 12-Dec-2012

3 3 Contents Roche Diagnostics Data Set; Objective and Characteristics Roche Diagnostics Data Set; Scope of Work GCP: Monitoring definition GCP: Monitoring purposes General Monitoring Scope of Julius Clincial Monitoring Definition of Roche Key Data (“Study Documentation”) from OPTIMIST Study Data Sets Contact persons Good Clinical Practice & Monitoring activities for a Roche Diagnostics data set of the OPTIMIST trial 12-Dec-2012 Julius Clinical ESB_EC

4 4 Academic Research Organization (ARO) Academic Excellence Operational Performance Julius Clinical Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial 12-Dec-2012

5 5 Good Clinical Practice Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording an reporting trials that involve the participation of human subjects. This guideline has been incorporated in the Dutch law. All principles are based on the 2 pillars of GCP: Protection of the trial subject: voluntary, with no pressure, oral and written approval, privacy protection Quality of trial data Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012

6 6 Informed Consent Procedure Informed Consent procedure: Check use of correct approved version Inform verbally Give time to consider participation and to ask any questions Have Informed Consent Form signed by all parties by themselves Check whether all the data have been filled in Give the subject a copy or have the subject sign 2 original ICFs Document on the patient status of EPD Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012

7 7 Attention points IC procedure Look out! The person conducting the IC procedure must be authorized for this by the PI The subject must always sign first The most recently approved version must be signed The subject must fill in her own name and signature date Study procedures may not start before the ICF is signed If the procedure develops otherwise, this must be documented on a Note to File Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012

8 8 #1 audit findings! No signature investigator; use of a stamp Signature date missing, incomplete or different Missing Informed Consent Forms Informed Consent Process not documented Signed after the first study procedure Signed by a non-authorized person Incorrect version used Patient Information Sheet and Informed Consent Form are a unit and must be filed together Patient Information Sheet/Informed Consent Form Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012

9 9 Data collection basic requirements Collected subject data must be unidentifiable: no name, patient number or date of birth on CRF or on correspondence Only data necessary for the specific objective as described in the protocol may be collected All CRF data must be present in the Source Data (paper or electronic) unless otherwise specified in the protocol If data need to be corrected, the original text must be crossed out in a way that it remains legible. The correct data must be entered and provided of signature, date and if necessary the reason of the correction The CRA needs limited access to Source Data of the study subjects Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012

10 10 Source Data requirements Traceable to the observer, by signature and date Readable and reported on a permanent medium Timely reported at the moment of the observation. Any later additions must be signed and dated Original the original observations Acurate and compleet reflection of the observation Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012

11 11 Noncompliance Noncompliance with the protocol, SOPs, GCP and/or applicable regulatory requirements Depending on the seriousness, noncompliance constitutes a deviation or a violation Protocol deviation: It does not influence the risks or advantages for the subject It does not influence the value of het collected data It was an unintended mistake of the study team Protocol violation: It leads to a risk for the subject, or It has an influence on the scientific value of the data, or There is proof that the mistake was intended and its consequences were overlooked Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012

12 12 Noncompliance documentation To document a deviation: Write a Note to File, unless the deviation can be explained on another document Indicate on the Note to File what was done to correct the mistake and what was done to prevent this mistake from happening again To document a violation: Write down the violation in the Source Data and/or the CRF Discuss with the sponsor the steps that must be followed Fill in a Protocol Violation form and indicate which steps are taken to prevent the problem from happening again Send a copy to the sponsor and file the original in the ISF Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012

13 13 Drug safety (1) Adverse Event (AE) Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Serious Adverse Event (SAE) Any untoward medical occurrence that at any dose: Results in death Is life-threatening (at the moment of the event) Requires inpatient hospitalization or prolongation of existing hospitalization Is a congenital anomaly/birth defect Results in persistent or significant disability / incapacity Exceptions must be established on the protocol! Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012

14 14 Drug safety (2) Procedure SAE reporting Consult the procedure in the protocol or study manual Fill in the SAE form and fax or a scan of this form within 24 hours of the Sponsor’s knowledge of the event (unless the sponsor is the coordinating investigator) The Sponsor reports the SAE in ToetsingOnline Send any additional documents or information via a follow-up form Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012

15 15 Drug safety (3) (SUSAR) Suspected Unexpected Serious Adverse Reaction Suspected – posibly related to the study treatment Unexpected - the nature or severity of the reaction is not consistent with the applicable product information Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012

16 16 Drug safety (4) Expedited reporting SUSAR (WMO) to CBG When the incident takes place under “your”protocol Within 15 days since the sponsor received the first information about the incident For fatal or life-threatening incidents, within 7 days When the incident takes place under another protocol Semi-annual line listing If the incident has far-reaching safety consequences, expedited timelines must be considered SUSARs must also be reported to the IRB/IEC, CA and investigators within these timelines Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012

17 17 Drug safety (5) Annual safety report (WMO) by the Sponsor During the whole study Once a year, together with the Study Progress Report Summary of every SAE and SUSAR in the study Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012

18 18 Basic requirements investigator According to the NFU guidelines, the investigators in University Hospitals must be BROK-certified. Investigators in other centres must have provable GCP knowledge (add GCP certification to the CV) Other study staff must be authorized by the PI before the start of the study The PI must take care that every person who works on the trial has been trained in the protocol, the IMP and the tasks/obligations The PI must guarantee that all those involved are qualified for the tasks that are delegated to them Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012

19 19 Essential documents Investigator Site File (ISF) A folder of the investigator containing all documents relevant for that specific site and all general documents applicable. The investigator or delegated party is responsible for maintaining the ISF. Archiving of files, CRFs en medical dossiers Standard: 20 years after the end of the study in University Hospitals (archiefwet) and 15 years in other Hospitals (GCP) Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012

20 20 Amendments Any changes to the study protocol or procedures must be approved by the METC before implementation Changes are considered substantial or nonsubstantial (only administrative changes) amendments to be submitted to the METC Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012

21 21 Study Objective: Roche Diagnostics is developing a new automated immunoassay for Anti- Müllerian-Hormon (AMH). Based on data collected from a sub- population of the OPTIMIST study population, Roche desires to study the value of the Elecsys AMH test in predicting the response to controlled ovarian stimulation in IVF/ICSI patients treated with a standard dose of 150 IU of recombinant FSH. Summary of sub-study characteristics: Optimist study participants women, age years, with an indication for IVF or IVF-ICSI receiving a standard stimulation dose of 150 IU/d FSH, only in the first cycle of treatment. Women will participate in this part for approximately 10 months. Roche Diagnostics Data Set; Objectives and Characteristics Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial 12-Dec-2012

22 22 Monitoring activities on site: February 2013 – March 2015 Last Patient First Visit: December 2013 On average 5 visits per site (depending on # of patients per site): 2 monitoring visits in 2013 (8 hours) 2 monitoring visits in 2014 (8 hours) 1 monitoring visit in 2015 (4 hours on site for monitoring of pregnancy outcome). Julius Clinical SOPs, Forms and Templates will be used Julius Clinical will not be involved in study management tasks like obtaining approval for any amended study documents Roche Diagnostics Data Set; Scope of Work Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial 12-Dec-2012

23 23 The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded and reported in accordance with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirements GCP: Monitoring definition Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012

24 24 GCP: Monitoring purposes The purposes of trial monitoring are to verify that: The rights and well-being of human subjects are protected The reported trial data are accurate, complete and verifiable from source documents (source data verification) The conduct of the trial is in compliance with the currently approved protocol/amendment(s), with GCP, and with all the applicable regulatory requirements Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012

25 25 General Monitoring Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial 12-Dec-2012 UMCU monitor will make appointment with site UMCU monitor will visit the site together with the Julius Clinical monitor Site will have a combined meeting with both monitors at the end of the visit UMCU monitor will be the major site contact in between visits UMCU monitor will sent requests to the site like queries, action lists

26 26 Scope of Julius Clinical Monitoring Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial 12-Dec % check on ICFs (re-consent form dated May 2012) 100% SDV for max patients who receive the standard dosis, the fertility work-up and first IVF/ICSI cycle (only 1. IVF cycle, no cryo cycle, Roche Key Data set) Check query process & assist Investigators in solving unanswered SDV queries (only 1 IVF cycle, no cryo cycle, Roche Key Data set) Check if study personnel has attended the OPTIMIST training meeting Write report within 3 weeks after every visit and send a copy to Roche and Study Coordinator

27 27 Definition of Roche Key Data (“Study Documentation”) from OPTIMIST Study Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial 12-Dec-2012 First Data Set: to include all key data as specified in the next slides until completion of first IVF treatment cycle except information upon Pregnancy Outcome. Second Data Set: to include all key data as specified in the next slides of first IVF treatment cycle including information about Pregnancy Outcome.

28 28 Data Sets Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial 12-Dec-2012

29 29 Data Sets Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial 12-Dec-2012

30 30 Data Sets Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial 12-Dec-2012

31 31 Data Sets Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial 12-Dec-2012

32 32 Data Sets Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial 12-Dec-2012

33 33 Data Sets Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial 12-Dec-2012

34 34 Data Sets Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial 12-Dec-2012

35 35Good Clinical Practice & Monitoring activities for a Roche Diagnostics sub-study of the OPTIMIST trial Versie: 06-dec-2012 Contact persons Principal Investigator: Prof. Dr. F.J. Broekmans, UMCU Study-coordinator: Dr. H.L. Torrance, UMCU PhD student: Charine van Tilborg, UMCU, UMCU monitor: Marian Kosterman Julius Clinical: Engelien Septer-Bijleveld, Project Manager Karin Groot, Senior Clinical Research Associate ; Eva Corral, Clinical Reseach Associate ; Karin Groot and Eva Corral will be the contact persons for the sites.


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