Protocol and Ethics

This page presents the full protocol, ethics, and other formalia for EFFECTS.

Latest version (v 4.9) of the research plan Click here.
Ethical approval (Dnr: 2013/1265-31/2. Date: 03/09/2013) Click here.
Amendment 1 (Date: 15/04/2015) Click here.
Amendment 2 (Dnr: 2015/991-32. Date: 10/06/2015) Click here.
Amendment 3 (Dnr: 2015/2056-32). Date 30/11/2015) Click here.
Amendment 4 (Dnr: 2016/1191-32). Date 14/06/2016) Click here.
Amendment 5 (Dnr: 2016/2531-32). Date 04/01/2017) Click here.
Amendment 6 (Dnr: 2017/638-32). Datum 2017-03-28) Click here.
Version history of the protocol (in Swedish) Click here.
EudraCT number:

2011-006130-16

Approval from the Medical Product Agency, Sweden

Approval date 2014-08-08, with (Diarienummer 5.1-2014-43006).

Registered at ISRCTN och Clinicaltrials.gov

EFFECTS is registered at  ISRCTN (ISRCTN13020412) and at Clinicaltrials.gov (NCT02683213).

Data Management Plan

Data Management Plan and Data Review Plan.

Statistical Analysis Plan (SAP)

Under review in Trials.

Funding and sponsor of the study

EFFECTS has currently received grants from the Swedish Medical Council, the Swedish Brain Foundation, the Swedish Heart-Lung Foundation, King Gustav V and Queen Victoria’s Foundation of Freemasons, the Swedish Stroke Association and the Swedish Society of Medicine. All funders are non-commercial, with none from industry.

None of the funders nor the sponsor had any role in the design of this study and will not have any role during its execution, analyses, interpretation of the data or decision to submit results.

In the future, the datasets acquired will be available from the Chief Investigator on reasonable request, after the publication of main EFFECTS’ results. The dataset will be saved in Karolinska Institutet’s electronic notebook

The sponsor is Karolinska Institutet, Danderyd Hospital, 182 88 Stockholm, Sweden. The sponsor’s representative is Erik Lundström .

Coordination centre

The coordination centre is located at Karolinska Institutet, Danderyd Hospital and those responsible for day-to-day management are Chief Investigator Erik Lundström, Trial Manager Eva Isaksson and Trial Manager Assistant Nina Greilert.

Steering Committee

The Steering Committee has the task of following the development of the study, assisting the Chief Investigator with advice and support when needed, and helping to solve problems. The Steering Committee is also responsible for ensuring that the protocol for the study is followed. The Steering Committee is responsible for:

  1. Policies, superior organisational issues and any technical issues
  2. The report of the Data Management Committee shall be received by the Steering Committee
  3. Monitoring finances, but Karolinska Institutet is the financial manager and manages funds
  4. Overseeing staff, but Karolinska Institutet has personnel responsibility
  5. Considering the need for any protocol changes
Dissemination policy

The Steering Committee shall ensure that a good publication policy is applied to the protocol which states that publications are prepared by persons approved by the Steering Committee. The study is dependent on collaboration with a large number of doctors, nurses, patients and relatives. Those included in the local centre (which are on the delegation list) will be included in a list. The publication is prepared by a writing committee. We follow the current International Committee of Medical Journals Editors Recommendations.[19]

Members of the Steering Committee

The Steering Committee consists of Professor Katarina Stibrant-Sunnerhagen (chair), Professor Per Wester, Professor Bo Norrving, Professor Håkan Wallén, Senior Professor Jörgen Borg, Senior Associate Professor Björn Mårtensson, Associate Professor/statistician Per Näsman, Chief Investigator/Associate Professor Erik Lundström, and trial manager Eva Isaksson.

Data management

The task of data management is divided between the centres, Karolinska Institutet, Karolinska Trial Alliance and EDC Scandinavia AB personnel, and all parties will ensure that qualified staff are available.

The responsibilities are divided up as follows:

Database design EDC Scandinavia
e-CRF design EDC Scandinavia, Karolinska Institutet & Karolinska Trial Alliance
Server management EDC Scandinavia
Data collection Centre & Karolinska Institutet
Data manager EDC Scandinavia
CRF annotation Centre, Karolinska Institutet & Karolinska Trial Alliance
Data entry Centre, Karolinska Institutet & Karolinska Trial Alliance (only central 6 and 12 months)
Monitoring Karolinska Trial Alliance
Source data verifications Karolinska Trial Alliance
Issue and resolve data correction forms Karolinska Institutet & Karolinska Trial Alliance
Medical coding Karolinska Institutet
Data validation EDC Scandinavia & Karolinska Institutet
Discrepancy management Centre, Karolinska Institutet & Karolinska Trial Alliance
Database lock. The database will be preserved according to Karolinska Institutet’s rules, the electronic notebook EDC Scandinavia
Data Monitoring Committee (DMC)

The Data Monitoring Committee (DMC) will independently monitor patient safety and efficacy information, and will study conduct, during the period of the trial. The DMC comprises two physicians with stroke expertise: Senior Professor Kjell Asplund (chair), Senior Associate Professor Kerstin Hulter Åsberg and a biostatistician, Anders Ljungström.

DMC members will not be involved as principal investigators or sub-investigators in the study. In addition, DMC members must not have a conflict of interest that would bias their review of trial data (e.g. DMC members must not have a financial interest that could be substantially affected by the outcome of the study, strong views on the relative merits of the study drug, relationships with individuals in trial leadership positions that could be considered reasonably likely to affect their objectivity, or involvement in any potential competing trial).

The unblinded statistician, a member of the DMC, will generate data and reports for the DMC to review. The Chief Investigator will serve as a primary contact person for the DMC and DMC issues.

As a rule, DMC contacts and consultants must not attend closed sessions of DMC Data.