Improving Quality Based on the Joint Registry
Phase: NA
Conditions: Registries, Quality Improvement, Hip Arthropathy, Knee Arthropathy, Hospital Performance
Sponsor: Leiden University Medical Center

Annex 2: Data Delivery Agreement 
 
 
Study name: Improving Quality based on the joint registry (IQ Joint study) 
 
 
Date of Document: 24 October 2018 
 
 
 
 

This Data delivery agreement (“Agreement”) is entered into as from 25 September 2018 (“Effective 
Date”) between   
 
Leiden University Medical Centre (LUMC), department of Orthopaedic surgery, an institution 
organised in accordance with the public law of the Netherlands, located at Albinusdreef 2, 2333 ZA 
Leiden, the Netherlands, hereinafter referred to as “IQ Joint Study Group” 
 
and 
 
[insert name centre], an [describe type of institution] organised in accordance with the public law 
of the Netherlands, located at [insert address], hereinafter referred to as “Centre”.  
IQ Joint Study Group and Centre shall be hereinafter individually referred to as “Party” and jointly 
as “Parties”; 
 
• Whereas the IQ Joint Study Group is a group of researchers involved in the collection and 
analysis of patient data on total hip arthroplasty (“THA”) and total knee arthroplasty (“TKA”) 
for the purpose of the IQ Joint Study (“Study”); 
• Whereas for the Study, the IQ Joint Study Group intends to collect patient data on THA’s and 
TKA’s in a combined database to facilitate health care institutions in defining the variation in 
performance on different outcomes and will communicate these performance outcomes to 
the Centre during the trial;  
• Whereas Centre is a health care institution performing THA’s and TKA’s, and as a result 
collecting anonymized individual patient data relating to such THA’s and TKA’s;  
• Whereas Centre wishes to participate in the Study and agrees to deliver patient data to the IQ 
Joint Study Group in order for the IQ Joint Study Group to enable data analysis for the Study;   
 
Therefore the Parties agree as follows: 
 
1.   Study conduct  
1.1 For the purpose and during the Study, the Centre will deliver anonymized data obtained from 
the Centre’s electronic patient file (“Input Data”) (which requested data is described in annex 1 of 
this Agreement (“Annex 1”)) to the IQ Joint Study Group. 
1.2 For the performance of the Study, the IQ Joint Study Group shall, in a reasonably timely 
manner, provide Centre with all necessary information required to perform the Study, or with 
access thereto and both Parties shall in general cooperate in good faith with each other.  
 
2.  Delivery and processing of the Input Data for the Study 
2.1 The Centre warrants and undertakes that it shall at all times collect and deliver the Input Data 
in accordance with this Agreement, the Study protocol, all reasonable instructions from the IQ Joint 
Study Group, generally accepted professional standards of the health care industry, including but 
not limited to those regarding clinical research (to the extent such are applicable) and all applicable 
laws and regulations, including but not limited to the applicable data protection legislation. 
2.2 The Centre warrants that the Input Data are the result of careful extraction of data from the 
electronic patient file. In case of questions raised by the IQ Joint Study Group after the submission 
of the Input Data by Centre to the IQ Joint Study Group, Centre shall promptly answer questions of 
the IQ Joint Study Group about the Input Data, and if requested by the IQ Joint Study Group, 
correct and complete such Input Data.    
 

2.3 In case of a conflict between the instructions in the Study protocol and this Agreement, the 
Study protocol will prevail for matters related to the Study conduct, except for the description of 
which data shall be collected, which is described in Annex 1 of this Agreement. 
2.4 The Centre acknowledges that Input Data will be integrated with the same type of data 
provided by other participating centres in the Study in order to enable the IQ Joint Study Group to 
conduct research in accordance with this Agreement and the Study protocol and to create a 
database through analysis and processing of the Input Data (“Output Data”). 
2.5 The IQ Joint Study Group will process the Input Data for the purpose of the Study and in 
accordance with this Agreement. The IQ Joint Study Group will ensure that it has in place and will 
maintain appropriate technical and organisational measures against unauthorised or unlawful 
processing of the Input Data and against accidental loss or destruction of or damage to the Input 
Data. 
 
3. Delivery Output data to Centre 
3.1 Monthly, the IQ Joint Study group will sent an email to all orthopaedic surgeons performing 
THA and/or TKA. The email contains a performance report with both individual outcomes and a 
composite performance outcome. The results are compared with the other participating 
centres.  
 
4. IPR  
4.1 All patents, trademarks, trade names, service marks, domain names, copyrights, moral rights, 
rights in and to databases (including rights to prevent the extraction or reutilisation of information 
from a database), design rights, topography rights and all rights or forms of protection of a similar 
nature, or having equivalent or the similar effect to any of them which may subsist anywhere in the 
world, whether or not any of them are registered, and including applications for registration of any 
of them (“IPR”) on the Input Data is and will remain with the Centre. All IPR on the Output Data is 
and will remain the exclusive property of the IQ Joint Study Group. Neither Party will make any 
claim against the IPR of the other Party. Communication on the Output Data by the Centre is only 
possible with the prior authorisation of the IQ Joint Study Group.  
4.2 The Centre grants the IQ Joint Study Group a royalty-free, non-exclusive licence in respect of 
Input Data to import and include such Input Data in the Study database. The Input Data may be 
used by the IQ Joint Study Group to enable statistical and research analysis for the Purpose of the 
Study, to answer the research questions as described in Annex 1. 
 
5. Further obligations 
5.1 Each Party warrants it has general and professional liability insurance in place to sufficiently 
cover its obligations hereunder.  
5.2 The Centre shall indemnify and hold the IQ Joint Study Group harmless against any and all loss, 
claim or expense suffered by the IQ Joint Study Group as a result of the Centre’s breach of its 
obligations hereunder. 
 
6. Term and termination 
6.1 This Agreement shall become effective as of the Effective Date and shall remain in force until 
completion of the Study or termination in accordance with this clause, whichever comes first. 
6.2 Either Party may terminate this Agreement with immediate effect by giving notice in 
writing to the other Party upon the occurrence of any of the following events: 
a.) If the defaulting Party commits a material breach of its obligations under this 
Agreement and (if the breach is capable of remedy) fails to remedy the breach within thirty (30) 

days of being specifically required to do so in writing by the non-defaulting Party. 
b.) If any distress, execution, sequestration or other similar process is levied or enforced 
upon or against property of the defaulting Party which is not discharged within thirty days, or an 
encumbrancer takes possession of, or an administrator, an administrative receiver, a receiver, a 
trustee or a liquidator is appointed over the whole or any substantial part of the defaulting Party’s 
undertaking, property or assets, or an order is made or a resolution is passed for the winding-up or 
analogous proceedings in any jurisdiction of the defaulting Party. 
6.3 The IQ Joint Study Group will have the right to terminate this Agreement for any reason upon a 
thirty (30) days written notice to the Centre or in the event that the IQ Joint Study Group identifies 
serious and/or persistent non-compliance with the obligations outlined in clause 1 and 2 of this 
Agreement regarding the collection and delivery of Input Data, the IQ Joint Study Group will have 
the right to terminate the Agreement with immediate effect and to remove the Input Data from the 
Study database. 
6.4 In the event of termination, Input Data that have already been analysed and used to 
generate Output Data will be kept available by the Centre for the IQ Joint Study Group for 
monitoring and/or auditing purposes for a period of fifteen (15) years after termination. 
6.5 The rights and obligations of the Parties under clauses 3, 4, 5.5, 7, 8.3 shall survive termination 
or expiration of this Agreement. 
 
7. Authorship and publication 
7.1 The IQ Joint Study Group intends to publish the results of the analyses of the Input Data in 
reputable scientific and medical journals and at scientific conferences. 
7.2 Authorship and acknowledgements follow the criteria established by the International 
Committee of Medical Journal Editors (“ICMJE”).  
 
8. Notices 
8.1 Any notices which are required to be given or which shall be given under this Agreement shall 
be in either in writing and delivered personally or delivered via a reputable delivery services or via 
e-mail addressed to the Parties as follows:  
To the IQ Joint Study Group: Prof.dr. R.G.H.H. Nelissen (e-mail:R.G.H.H.Nelissen@lumc.nl) 
To the Centre: [insert name and address (including e-mail)] 
 
9. Miscellaneous 
9.1 Assignment. This Agreement shall not be assignable by either Party without the prior written 
consent of the other Party. 
9.2 Independent contractor. For the purposes of this Agreement and all services to be provided 
hereunder, each Party shall be, and shall be deemed to be, an independent contractor and not an 
agent or employee of the other Party. Neither Party shall have the authority to make any 
statements, representations or commitments of any kind or to take any action which shall be 
binding on the other Party, except as may be explicitly authorised by the other Party in writing. 
9.3 Governing law and jurisdiction. The validity and interpretation of this Agreement and the legal 
relationship of the Parties to it shall, in all respects, be governed by the laws of the Netherlands. 
Any and all disputes between the Parties that cannot be settled amicably shall be subject to the 
exclusive jurisdiction of the court having competence in any such matter at Leiden, the 
Netherlands. 
9.4 Entire agreement including annexes and modifications. Unless otherwise specified, this 
Agreement (including the annexes thereto) embodies the entire understanding between the 
Parties, and any prior or contemporaneous representations, either oral or written, are hereby 

superseded. No amendments or changes to this Agreement shall be effective unless made in 
writing and signed by authorised representatives of the Parties.  
 
 
 
AGREED AND SIGNED BY BOTH PARTIES: 
 
IQ Joint Study Group 
 
 
 
Orthopaedic surgeon in participating centre: 
 
Name: Prof. dr. R.G.H.H Nelissen 
 
 
Name: __________________ 
 
  
 
 
 
 
 
 
 
Date: 17-12-2018  
 
 
 
Date: ___________________ 
 
  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Research questions IQ Joint Study Group relating to part 2 of the IQ Joint study: 
1. Defining the variation in Dutch hospitals performing THA and/or TKA  in participating 
hospitals and to what extent this variation is explained by patient mix, fixation of the 
prosthesis, surgical approach, pre-and postoperative processes. 
2. Combine the outcomes in a hospital performance profile (textbook outcome). 
3. Testing whether an intervention consisting of frequently feedback of performance data 
leads to better outcomes, more effective use of joint registry and more activities with 
the aim of improving quality.  
 
 
Provided data by Centre: 
Following data will be sent monthly to the IQ Joint study group for all patients undergoing a 
total hip or total knee replacement. 
 
LROI data + additive variables, namely: 
• 
Length of stay in days (defined as discharge date – admission date) 
 
• 
Readmission (Yes/No) and 
o Number of days after operation date 
o Number of days after discharge date 
 
• 
Reoperation other than revisions (Yes/No) and 
o Number of reoperations 
o Number of days after operation date of first reoperation 
o Number of days after discharge date of first reoperation 
 
• 
Wound infections related to the operation (Yes/No) and 
o Number of infections 
o Number of days after operation date of first wound infection 
o Number of days after discharge date of first wound infection