FAQ

General Questions

What is NARCRMS?

The North American Registry for Care and Research in Multiple Sclerosis (NARCRMS) is a physician-based registry and longitudinal database of clinical records and patient center outcomes.  NARCRMS allows the linkage of MS centers and allows stakeholders to freely access de-identified data. NARCRMS is the first open access database to link North American MS Centers in the US and parts of Canada.

Updated – 8/2/2016

How is NARCRMS governed?

NARCRMS is a special project of the Consortium of Multiple Sclerosis Centers (CMSC) and is overseen by the CMSC Board of Governors (BOG).  NARCRMS also has a Steering Committee (SC) which is comprised of key leaders from the field and sets policies for NARCRMS operations; commissions or initiates key questions to be addressed and formulated; reviews recommendations for tests, assessments, and other information to be included in the NARCRMS database; provides suggestions for data harmonization and data collection; develops strategies for expanding collaborations with other registries and health research groups; assists with developing funding strategies; and assists with developing data access policies.   An Executive Committee was also implemented and is a subcommittee of the SC.  The Executive Committee assists the NARCRMS Leadership and Operations Center with managing issues and making decisions related to the daily operation of the NARCRMS network.  An organizational chart of NARCRMS can also be found at http://narcrms.org/organization-structure/.

Updated – 8/2/2016

How is NARCRMS funded?

NARCRMS currently receives funding from the Consortium of Multiple Sclerosis Centers (CMSC) and by numerous pharmaceutical industry sponsors.

6/15/2016

Does NARCRMS have a National Clinical Trials (NCT) Identifier Number?

No. NARCRMS is not a clinical trial and does not have a NCT.  A NCT may be obtained in the future if needed.

6/15/2016

Does NARCRMS use a HIPAA compliant system?

Yes.  NARCRMS uses an OpenClinica application for the registry which enforces controls such as password policies, audit history, role based access control, and user access log.

6/15/2016

Will NARCRMS utilize a central IRB?

Sites should follow local requirements for IRB submissions.  If use of a central IRB is permitted, we would recommend the use of Western Institutional Review Board (WIRB), since NARCRMS has already been approved by WIRB.

Updated – 8/2/2016

Our IRB will require that we set up a data usage agreement and have a working budget in place before IRB submission. Can these items be facilitated?

A clinical center agreement, which will address data usage and includes budgetary information, will be provided to participating MS centers.

11/12/2015

Our IRB prohibits collection of DOB, or has restrictions related to when it may be collected. What should we do?

NARCRMS has been updated and will no longer collect DOB; instead, year and quarter of birth will be collected. If your site’s IRB prohibits collection of year/quarter of birth or requires a data usage agreement or business associate agreement (BAA) in order to collect that information, please notify the NARCRMS Operations Group (NARCRMSOps@s-3.com). We can work with you to determine whether wording in the clinical center agreement is sufficient to satisfy the IRB, or determine the most appropriate path forward based on your specific requirements.

Updated – 5/9/2017

 

Should my site submit for a HIPAA Waiver?

Each participant must sign a HIPAA authorization form, and the site must keep a copy on-file, as NARCRMS will collect limited PII (year and quarter of birth as well as zip code) from each patient.  A template HIPAA authorization form has been incorporated in the NARCRMS Sample Informed Consent form and sites may modify the form as required by their IRB.  NARCRMS also recommends that sites apply for a partial HIPAA waiver, as this waiver allows the site investigator or site staff to review patient records in order to identify potential subjects for recruitment into NARCRMS.

Updated – 5/9/2017

 

Will NARCRMS utilize a lead study site?

Unlike in clinical trials, NARCRMS will not have a study PI or a lead institution since this is a database.   Please review the governance structure of NARCRMS for more information.

12/22/2015

Will there be a coordinator phone conference at some point?

Yes.  We have held some initial training calls and webinars and continue to schedule others as sites receive IRB approval.  In addition, the webinars will be recorded and housed on the NARCRMS website for future reference.

Updated – 5/9/2017

 

Who enters data into the data collection system (OpenClinica)? Does the patient enter their own information?

At this time, data is obtained by site staff via the patient’s medical history or during patient visits and is entered by the site staff into OpenClinica. NARCRMS also recommends that data be entered directly into the OpenClinica system as collected and not be copied from paper CRF forms into the data system. Over time, other avenues for data entry may be developed such as patient-reported outcomes.

Updated – 5/9/2017

 

Are there any restrictions on what can be obtained via telephone?

No.  In fact, it may be best to conduct a phone interview first so the patients can be prepared with information about past history, immunizations, etc. when they come for the initial face-to-face visit.

11/13/2015

Is there any honorarium for patients?

No, not at this time.  Eventually, we will make their data available to the patients, which will be the incentive to participate.  Later, when we add the Bioinformatics/Biostatistics Core, we may provide information to each patient as to where they compare to the whole cohort matched for variables including disease duration, DMT used, etc.  We will monitor enrollment and retention to determine whether we need to reconsider some incentive payment.

11/13/2015

Will sites receive reimbursement for patient enrollment?

NARCRMS plans to reimburse sites on a per patient basis. A clinical center agreement, which will address data usage and include budgetary information, was provided to participating MS centers and includes more detailed information about site reimbursement. Sites will receive $600 annually per patient. Although the MRI and Biomarker cores have not gone live yet, this amount will include the cost for entering a complete set of CRFs for the visit, uploading MRI and shipping Biomaterials. Cost for collection and mailing will be extra, part of the biomarker core budget. This amount will also include the unscheduled visits for exacerbations or change in DMT. For patients on treatment the annualized relapse rate will be in the 0.3 range so most patients would not be expected to experience relapses.

Updated – 2/29/2016

What is the NARCRMS policy on indirect rates for sites?

NARCRMS is a project of the CMSC which is a 501©3 non-profit organization directed by a voluntary Board of Governors who develop and approve all policies and procedures.  Sites may add an amount for indirect costs up to 10% of the sum requested by the principal investigator except that indirect costs are not allowed in connection with funds requested or expended for: (a) patient costs; or (b) purchase, modification or installation of equipment.

10/18/2016

Why is NARCRMS data collection limited to 5 years per patient?

The first five years is the pilot phase of NARCRMS.  After five years, NARCRMS will consider expanding the registry to include sites all over the world, or develop a plan for federating the database to allow searches to be performed on valuable MS data sets that reside in different locations outside of the US. Such expansion would make it an even more valuable resource for the scientific, medical and regulatory community.

6/15/2016

Is there an exam form collected as part of this registry? Is there an annual EDSS?

While full exam forms are not currently entered into the registry, limited clinical exam information is entered into the registry at enrollment, each exacerbation, and each follow-up visit. EDSS results are collected in this form (collected at least annually). Discussions about how best to enter full and complete neurological examination information are ongoing, and additional entry may be added over time.

2/29/2016

Does the EDSS rater need to be a certified rater or a physical therapist, nurse practitioner (NP) or Doctor of Nursing Practice (DNP) complete the EDSS assessment?

The EDSS assessment may be performed by a certified rater, NP, DNP or any other site staff that performs EDSS for clinical trials.

6/15/2016

Can a patient with an EDSS higher than 6.5 be enrolled?

No. The NARCRMS inclusion criteria state that patients enrolling in NARCRMS must have an EDSS of 6.5 or less. As NARCRMS is a longitudinal registry, inclusion criteria must be selected and the Leadership determined that severely affected patients with an EDSS higher than 6.5 should not be enrolled.

5/9/2017

Should my site use a specific version of the EDSS?

NARCRMS requests that sites use the EDSS form recommended by the National MS Society.  The form can be found at http://www.nationalmssociety.org/For-Professionals/Researchers/Resources-for-Researchers/Clinical-Study-Measures/Functional-Systems-Scores-(FSS)-and-Expanded-Disab

5/9/2017

 

Month of birth visits – this may create problems logistically. First, can the initial baseline visit be ANY month, or does that also need to be month of birth? The latter would create even more logistical problems. Can this requirement be relaxed?

Yes, the initial visit can be any month and the annual visit can be one year from the initial visit.

11/13/2015

Is there a window for completing annual follow up visits?

NARCRMS recommends that annual follow up visits be completed as close to one year after the previous visit as possible.  As such, sites should conduct annual visits at least 9 months after and no more than 18 months after the last visit.

5/9/2017

What about CIS patients with high probability to develop MS? (Such as + CSF plus typical MS MRI, but not meeting 2010 McDonald criteria)? May they be enrolled?

Yes, CIS patients may be enrolled. However, RIS patients are excluded.

11/13/2015

What should my site do if an enrolled patient does not know the exact answer to a question in NARCRMS?

We ask that patients and sites provide as complete information as possible.  If a patient does not know an exact answer to a question (e.g. date of vaccination) then the system will allow the site to enter a partial date (e.g. year of vaccination) however sites should still provide as much information as possible.  In the event that a patient cannot provide partial information (e.g. year of vaccination) then the site will have the option to use the response “no information”.

5/9/2017

Regarding annual MRIs, what if patients do not want to have them due to high co-pays, or other reason? What if they are every 2-3 years rather than yearly? Mostly our newer patients get yearly MRIs, but not always when they have been stable for several years.

Every effort should be made to encourage the patients to have annual MRIs. Site staff should explain to patients why it would helpful and important as part of this longitudinal follow up study and that information may be learned if their disease subsequently progresses. Annual MRIs are not considered excessive by insurance payers and the cost for annual MRIs should be billed to insurance as part of standard of care. CMSC may consider reimbursing for MRI co-pays not covered by insurance.

11/13/2015

Can the MRIs be done on an OPEN MRI for patients otherwise eligible but claustrophobic?

No, the MRIs should be performed on the same scanner for all patients, similar to a clinical trial. It is best to exclude patients who are claustrophobic for regular MRI.

11/13/2015

We are assuming that MRI does not need to be done at our facility – is that correct?

No, but the MRIs should be performed on the same scanner for all patients, similar to a clinical trial.  The scanner will also need to be certified for quality by the Neuroimaging Core at the University of British Columbia.  There are a number of good scanners outside the University setting, but the facility must be willing to perform the minimum sequences to certify them as useful scans. The minimum required MRI sequences can be found at http://www.mscare.org/?page=MRI_protocol.

11/13/2015

Will PASAT, CVLT and/or SDMT be conducted?

NARCRMS will ask sites to conduct PASAT, CVLT and SDMT however PASAT is optional.  Results will be recorded in the database.

Updated – 5/9/2107

 

Should sites administer the long or short version of the CVLT?

Sites may use either the long or the short version when administering the CVLT on behalf of NARCRMS.

5/9/2017

Should sites administer form A or form B of the SDMT?

Sites can administer either form A or form B of the SDMT and do not need to rotate between forms annually when administering the SDMT on behalf of NARCRMS.

5/9/2017

What chart should be used for the low contrast visual acuity test?

NARCRMS recommends that sites use the SLOAN chart for the low contrast visual acuity test as is used by most MS clinical trials.

5/9/2017

Will personally identifiable information (PII), e.g. DOB be visible to those viewing the NARCRMS data?

The majority of PII collected by NARCRMS will only be available to the site that enrolls the patient.  Minimal PII (year/quarter of birth and zip code only) will be available to those viewing NARCRMS data. All stakeholders such as MS Centers, pharmaceutical companies, sites, and, in the future, governmental agencies, will have access to data in a de-identified reporting format such that the only PII shared with stakeholders/individuals accessing the database will be year/quarter of birth and zip code.

Updated – 5/9/2017

 

Will stakeholders accessing NARCRMS data need to sign an agreement pledging not to identify patients?

No.  The majority of PII will only be available to the site that enrolls the patient and as such NARCRMS does not need special agreements with stakeholders accessing the de-identified data.

Updated – 5/9/2017

 

What level of data will each stakeholder be able to view?

Sites will not enter any patient name, address, or phone number into the registry to preserve confidentiality; however, quarter and year of birth, and zip code (city) will be entered and will be available through the web-based reporting tool.

Participating Site Personnel – All data entered are de-identified and will be available through the reporting tools.

Industry/Pharmaceutical Representatives – All data entered are de-identified and will be available through the reporting tools.

Patients – General information about how the patient fares in relation to other patients enrolled in NARCRMS.

Updated – 5/9/2017

 

What happens if a patient withdraws consent after being enrolled in NARCRMS?

If a subject withdraws consent after being enrolled in the database no future data will be collected but per the informed consent form, the subject will allow future use of their data that was previously collected.

8/2/2016

Where will NARCRMS store the data?

The NARCRMS database will reside in a secure server located at Social & Scientific Systems, Inc. (SSS) in Silver Spring, MD.

12/22/2015

Will there be limits on the data’s intended future use (e.g., for MS research only)?

NARCRMS is a longitudinal database on MS. Data will be collected and used for research in MS. While NARCRMS intends to maintain and use the data indefinitely, short- and long-term goals have been and will continue to be developed.

12/22/2015