Dansk Forening for Data Management General Meeting 2017

Agenda 1. Election of chairman 2. The President’s report Dansk Forening for Data Management Agenda 1.        Election of chairman 2.        The President’s report 3.        Presentation and approval of financial report 2016 4.        Presentation and approval of budget and activities 2016 - including endorsement of membership fee 5.        Update of the declaration 6.        Election of Treasurer, Executive Officers, Alternating Officers, and Auditor 7.        Proposed motions            - Suggestion from DADM Board to pay President & Treasurer roles - (e.g. 2000 DKK/year), as there is a lot of adm. associated to these roles 8.        Miscellaneous BREAK

Agenda Dansk Forening for Data Management 16:00 RBM - Risk-based monitoring Define/interpret the key RBM concepts in CDM terminology and context RBM areas and activities along the study process – map to CDM responsibilities and tasks Present a suggested CDM checklist for RBM: Where to look, how to look, what to do   17:30 Off for dinner (Rungsted Kro)/See you later 

Planning Meetings/Events/Courses for 2016 Network – INCDMA Dansk Forening for Data Management Report of 2016 Board Meetings Planning Meetings/Events/Courses for 2016 Network – INCDMA Guidance from CFDA rg. Risk-based vs. 100% SDV Notes from INCDMA meeting: ·         Continuing on a discussion associated with the Chinese State FDA (still draft) requirements for a DM Report, Silvia and Ibrahim pointed us to the direction of a September report by the Chinese authorities alluding to widespread fraud in clinical trials (http://www.pharmafile.com/news/509123/80-chinese-clinical-trials-data-fabricated ). In that sense there might be a rationale base for stricter reporting and monitoring requirements in studies conducted in China, including those DM reports which we should then more favorably re-examine and support. -    As we are seeking more information and perspective on this topic, we’d like to ask our Chinese Roche colleagues (Charlin Qi and Li Han) to consider organizing a webinar for us – at a time of their convenience. Charlin/Li please contact Yiannis as soon as possible for us to arrange a TC on the topic. No presentation is required, but if you can find (through the SFDA website for example) more specific data or a translation of the actual Chinese authorities report or formal statement it will be a great help.

Report of 2016 Courses/Events in 2016 Dansk Forening for Data Management Report of 2016 Courses/Events in 2016 Summer Meeting at Ferring (June ~50 ppl) ePRO/eCOA and BYOD Guest speakers from CRFHealth, S-Cubed, Triticon Dinner DADM GCP Course for DM (Oct ~20 ppl)

Dansk Forening for Data Management Report of 2016 Ideas for 2017 DADM mini conference as Summer Meeting – Suggestions so far … WHODrug course eIC/eSource/Direct Data Entry Handling of pseudo-anonymised (blinded) data in clinical trials Handling Global Data Protection Regulations & Data Integrity Latest regulatory updates/requirements e.g. CDISC/SEND

Dansk Forening for Data Management REGNSKAB 2016

Dansk Forening for Data Management Regnskab for året 1. januar 2016 til 31. december 2016 Indtægter Regnskab 2016 Personlige kontingenter 32100,00 I alt Udgifter Bestyrelsesarbejde 4.676,00 Medlemsarr., møder og kurser 14.412,75 Internet/support/gebyrer 583,80 19672,55 Resultat 12427,45 Balance Beholdning primo 29828,72 Årets bevægelser 12442,45 Beholdning ultimo 42256,17

Regnskab 2016 Balance Beholdning primo 29828,72 DKr Dansk Forening for Data Management Regnskab 2016 Balance Beholdning primo 29828,72 DKr Årets bevægelser +12427,45 DKr Beholdning ultimo 42256,17 DKr

Dansk Forening for Data Management BUDGET 2017

Personlige kontingenter 30.000,00 DKr I alt 30.000,00 DKr Udgifter Dansk Forening for Data Management Budget 2017 Indtægter Personlige kontingenter 30.000,00 DKr I alt 30.000,00 DKr Udgifter Bestyrelsesarbejde 6.500,00 DKr Bestyrelsesarbejde kass 2.000,00 DKr Bestyrelsesarbejde form 2.000,00 DKr Medlemsarrangementer 35.000,00 DKr Internet og gebyr 600,00 DKr I alt 46.100,00 DKr Resultat -16.100,00 DKr

Dansk Forening for Data Management Update of declaration

Executive Officers (two years) Alternating Officers (yearly) Dansk Forening for Data Management Election of: Treasurer (two years) Executive Officers (two years) Alternating Officers (yearly) Auditor (yearly)

Dansk Forening for Data Management Proposed motions: Suggestion from DADM Board to pay President & Treasurer roles (e.g. 2000 DKK/year), as there is a lot of administration associated to these roles