Dansk Forening for Data Management

Link:

 DADM_General_Meeting_minutes_2021.doc (178.50 kb)

Answer from eClinical Solutions from the presentation:

  There was a question in the Teams Chat from Mette Ravn:

 ‘Do you have any thoughts about the Schrems II EU judgement (GDPR dilemma), not allowed in EU, using US cloud providers, that you could share?’

I asked eCS legal/regulatory about this and like with a lot of these types of topics related to data privacy, the picture can be a little murky and changes in line with the ever changing regulatory picture.  I thought I would share with you what they responded with.  Feel free to share with Mette and the wider group if they are interested in this response!

eClinical Solutions complies with all applicable data privacy laws.  We partner with our clients to understand the types, categories and flow of data with the expectation that the Data Controller is in the best position to know and identify where their data is coming from.  While eClinical Solutions is EU and Swiss Privacy Shield Certified, understanding the current unknown future of Privacy Shield, we also enter into Standard Contractual Clauses (SCCs) and other legal transfer mechanisms to ensure continued compliance with the General Data Protection Regulation (GDPR).  eClinical Solutions works with our clients to identify and adopt any required supplementary measures and continues to monitor changes to the fluid data privacy and security landscape with internal and external resources.

DADM_General_Meeting_minutes_2021.doc (178.50 kb)

DADM_v3 eCS slides.pdf (1.21 mb)

Wishing you a happy New Year,

DADM_v3 eCS slides.pdf (1.21 mb)

The availbe powerpoint presentaions are found under each subject in the program below.

Thank you for a good conference.

The DADM board is looking for more subjects to present this year.

If you have any ideas, please mail danskforeningfordatamanagement@gmail.com

Kind regards 

DADM board

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Despite the situation, DADM is still going strong. The rules in Pharma have forced us to hold the annual conference online. The conference will take place on 5^th of October 2020.

We have collected several speakers and exiting topics, as you see in this program

After the event, you are invited for dinner in real life in Lyngby.

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IB Alstrup, DADM questions raised on beforehand:

Decommisioning:

• How should sponsors document the system functionality? Are PDF files including the data and pictures of how they were gathered (blank CRFs) sufficient?
• Investigators access to data. Is it fine to revoke the access when sponsor have received acceptance of receipt of the hard drive containing the data from sites?
• Audit trail. Is it fine to have this as PDF file only (hard to search for specific data changes)?

Ongoing:

• How much review of the audit trail is expected from the regulators? (Please provide examples of which kind of data and reviews you will expect us to look at) Is it sufficient to look for trends ‘by sites’ and ‘by data items’?

 New devices/ways of collecting data:

• Before starting working with a new system, what QC is expected to the audit trail functionality? How is this dependent of whether the system is seen as SAAS (Software As A Service)
• BYOD (Bring Your Own Device). What to focus on when documenting why data is collected this way? – When is better patient compliance outweighing the risk for ‘wrong’ data (registered by someone else or local setting changed)?
• Automatic data collection tools (e.g. activity trackers). What to focus on when documenting which data are used? In general a data mining is taking place and the algorithm is not known to the sponsor. Do we need to archive the raw data, or could the data mining result be defined as raw data?
• Any new device. What to focus on when documenting why this device is used. What kind of mitigations are expected to see?
• How are the documentation dependent on the way sponsors use the software? SAAS or sponsor ‘owned’ – and in what category do we see the mobile apps?

Ib Alstrup DKMA Audit trail Review- the expectation from DHMA to the Sponsors: -   IBAL_DKMA_QA.pptx (3.20 mb)

Jennifer Logue Nielsen. Novo Nordisk: Highligths from the new eClinical Forum paper on Audit Trail Review    ATR_DADM_05OCT2020.pptx (4.40 mb)

Daiga Grunte-Sonne, Kromann Reumert Data Protection - in a clinical context     Data_management_and_GDPR.pptx (2.94 mb)

 Christine Dali, Orphazyme: Investigator experience from Participation in a Clinical Study    PI_experiences_presentation_Oct_5_2020.pptx (2.36 mb)

General meeting DADM 26 February 2020

 Minutes

The General meeting was held at Lundbeck with participation of 34 people.

Conductor: Carsten Junge

Reporter: Gitte Kruse            

The notice for the general meeting have been send out in a timely manner according to the valid regulation.

President report

Ibrahim Kamstrup-Akkaoui went through the annual report and informed of all the activities during 2019.  The President report was hereafter approved.

Financial result

The financial result was presented by the cashier and was hereafter approved without any comments.

Budget 2020

The budget was presented by the cashier and membership fee suggested to remain at 350 kr. per person. The budget for 2020 was approved without comments.

Election of executive committee

The executive committee as it looks after election is listed below. A few committee members were replaced per request.

• Britt Bech Andersen (re-elected 2 years)
• Mette Ravn (re-elected 2 years)
• Frank Jensen (re-elected 2 years)
• Poul Knoblauch (re-elected 2 years)
• Gitte Kruse (not on election)
• Lene Haastrup (not on election)
• Katja Bernstein (not on election)
• Kim Sonne (new committee member. Replaces Bo and is therefore only elected for the remainder of Bo’s election period and will be on election again next year)
• Mette Schledermann Larsen (new committee substitute)

• Bo Roat Jørgensen (left the executive committee)
• Ibrahim Kamstrup-Akkaoui (left the executive committee)

• Lisbet Groes continues as auditor.

Correction of wording in $4

A minor wording in $4 in the regulation regarding compensation, was by mistake not updated. The suggestion it-self was already approved in 2017, so this only relates to the wording in $4. The re-wording was approved. 

Proposed motions

None

Consolidating

The executive committee was consolidated with

Chairman Katja Bernstein

Treasurer Lene Haastrup

Secretary Gitte Kruse.

Dear All,

Thanks for your active participation in the conference and hope that it lived up to your expectations. Remember that you also have an influence on the topics and is welcome to share too.

Please find the presentations from the conference below.

Best regards,

DADM Board

DADM_encapsia.pdf (855.39 kb)

DADM_Knowit_Robotics.pdf (1.84 mb)

DADM_PD_Ferring.pptx (716.20 kb)

DADM_PD_Larix.pptm (1.82 mb)

DADM_SAS.PDF (4.07 mb)

Dear All,

It is a great pleasure to be able to invite you to an exciting event, with national and internationel topic experts (sign-up form is below the program). Thanks for all your great input on topics again this year!

Please sign up immediately and no later than 17-Aug-2018, so that we can arrange the practicalities. Conference fee is 200,- per attendee.

Looking forward to see you at the event,

DADM Board

Please see the job add in the file below.

Best regards,

DADM Board

Experienced_Data_Manager_Job_add_25May2018.docx (102.62 kb)

Dear All,

Please find the course materials below.

See you again at the DADM full day conference on 30th August 2018!

Best wishes,

DADM Board

Basic_GCP_Refresher_updated_2018.pdf (2.09 mb)

Data_Integrity.pdf (532.73 kb)

ePRO_and_Mobile_Apps.pdf (767.64 kb)

Inspection_and_Audit_Trends.pdf (974.70 kb)

Round_up_2018.pdf (1.06 mb)