All dates are date-shifted during the deidentification process which happens when the data are exported from your site

Some IRBs treat this registry like an intervention trial and apply standards that might not be totally appropriate for a registry. They may ask for a research protocol as if this is a clinical trial or an interventional trial. Note that in the Dartmouth IRB Registry Application, the application is an "APPLICATION FOR REVIEW FOR RESEARCH OR DATABASE DEVELOPMENT INVOLVING ONLY CLINICAL HEALTH INFORMATION OR SPECIMEN USE OR USE OF SECONDARY RESEARCH INFORMATION OR SPECIMENS.” So, it wasn’t reviewed like an intervention trial and shouldn’t be considered that way.

You can choose whether to participate in long-term follow up in addition to the basic registry.

You have options. If you are nonprofit, you can choose to install redcap on a server at your center. If you want to put your data into the redcap at Dartmouth-Hitchcock then you would need a data use agreement for that.

You do not need a data use agreement to export the data from your redcap to the de-identified registry. No identifiable data goes into the multicenter registry.

We have a secure encrypted method to upload the data. In addition, the data are de-identified when exported from your redcap.

In the consortium agreement you are agreeing to collect data on all patients. If your IRB requires a consent form, then you just need to keep in mind the data completeness policy (enclosed and on website). We have a waiver of consent for the main registry and use a consent form for the long-term follow up.

No, but the steering committee has the ability to set a membership fee. If your center does not want to pay the fee you can leave the registry. You will have representation on the steering committee.

All dates are date-shifted during the deidentification process

Many centers have a waiver of consent approved by their IRB for the registry. In other words, at many centers there is not a separate consent form for the registry. Here’s the explanation for why we have for the waiver of consent

The IRB follows the established guidelines in 45CFR46.116. Briefly, the four criteria are:

• Minimal risk: The registry fits this definition because only de-identified data are pooled.
• Would not adversely affect rights and welfare of subject: The outcome measures used in the registry are all clinically useful and are worthwhile measures for monitoring the quality of care at each center, regardless of a center’s participation in the pooling of de-identified data for research. These are measures that arguably should be done in some form at each center as part of clinical care, and so are not new measures or interventions that might affect the patient’s treatment. The REDCap registry at Dartmouth has good data security measures in place and the use of de-identified data minimizes risks to patients/participants. Also, these data are important for future patients and society. We understand and support the Principle of Respect for Persons (Common Rule) which indicates each individual has the right to make decisions about the use of his/her own private information - but there is also a responsibility to future patients to assure people are receiving effective, well studied interventions. We consider the waiver of consent justified as these data will be securely managed, are not particularly sensitive or stigmatizing, and will benefit future patients and society.
• Research could not be practicably carried out without the waiver: Research looking at issues such as outcomes/ morbidity data where not having access to all subjects would affect the statistical outcome is the type of research where obtaining consent can be considered impractical. For this registry, some indications for treatment are rarely or infrequently seen at each center and omission of data, or data from only a subset of subjects, could affect the statistical outcomes and damage the credibility of the registry results. This is also true if cases that did particularly well or particularly poorly are not included. Because there are so little data in this area a 100% sample is needed to characterize actual treatment and remove the bias of only those who actively consent. These data could be collected and used for quality activities - but the need is for generalizable information that can be applied to optimize care in multiple settings.
• Whenever appropriate, subject provided with additional pertinent information after participation: Not appropriate in this case, since results in the combined database are de-identified and so cannot be linked back to a particular person from the combined database. But, each center retains the ability to identify patients after their treatment is complete which allows centers to contact their patients in the event that the study identifies a risk or benefit in the future. We expect research results using registry data to be disseminated to clinicians and hospitals and hope that this knowledge will improve care at the individual level in the future.

When you enter the data each patient is assigned a unique registry identifier (e.g. 50000-101). At your site you will keep a record of name, MRN, etc. for 50000-101 so that you will know which patient that is.

You will be entering data into the Dartmouth-Hitchcock REDCap. This requires a Data Use agreement because you will be entering dates when you are entering data. All identifiers are removed when the data are exported to the Registry at Dartmouth College. In the de-identified registry date of birth is replaced by birth year and all the dates are shifted.

Your local REDCap will have identifiers in it and is very useful for our operations. You can use the identifiers to find additional information about particular patients, run reports, etc. Importantly, none of the identifiers go into the de-identified registry at Dartmouth College.

No, this is already covered in the Consortium agreement that your center already signed. No additional data use agreement is needed with Dartmouth College.