Can I get ISIS help 24/7?

• NUIT's technical help desk will be available during their regular business hours.
• If you have questions about policies, expectations, applicability, navigation, safety, and so forth, you may click on a link on each ISIS screen that will present several options for getting help. It is important to note that ORS is staffed only during regular business hours and that many ORS program managers and specialists spend a great deal of time in the field. ORS specialists will respond to your inquiry as soon as possible. If you are working in the ISIS application and have a question or encounter a problem, there may be a delay in responding to you.
• Remedy is a web-based application that allows tracking of support desk incidents. Users will be able to obtain help desk support by entering an incident "ticket" into the web-based Remedy system. Help desk support staff can easily route the incident tickets to the appropriate staff for resolution.

What should I do to prepare for data entry?

• ISIS will ask you to list your laboratory room numbers; a selection list will be provided, however it may not contain all rooms. If one or more of your room numbers do not appear, you may select "not listed" or alert ORS via the help options so that ORS can add it.
• ISIS will ask you to list your laboratory workers. You should have their netIDs available.
• If you currently have a radioactive materials authorization you will be required to re-enter most of the information you included on original applications, additions, and increases.
• If you currently have a recombinant DNA registration or a laser registration, have those forms handy; you will need to re-enter the information.
• Your Safety Plan could be a useful reference.

How much time will I have to complete entering data into ISIS?

Investigators must complete data entry within 1 month of the start date for their cohort. ORS will monitor entries. At the end of the first week ISIS will send a reminder to investigators who have not begun the process. At the end of the second week ORS will contact investigators who have not begun the process. At the end of 30 days, ORS will generate a report listing the investigators who did not complete the process. The report will be forwarded to the Vice President for Research for action. The purposes of controlling entry and compelling investigators to complete data entry within the 1 month window are to achieve compliance and to smooth out the compliance and service curve over the entire year.

ISIS is a pretty busy program; why so much text?

ISIS is not like a Power Point presentation or many web applications. It has been developed to meet specific compliance and information management requirements. There are 3 basic reasons for the amount of text. First, ISIS is intended to be an educational tool as well as a compliance tool. Second, some sections include text that must appear on registrations and applications. Third, in some sections PIs must agree to follow basic protocols and to add laboratory-specific protocols. The basic protocol text with which the PI must agree appears on the screens and reports.

I don't see a "DONE" button. How does ISIS know when I'm finished entering all of my data?

As you complete each of your required safety forms, an indicator on the left side of your Safety Forms page will change from red (incomplete) to green (complete). When you complete the set of forms that comprise your Laboratory Safety Profile and any forms that are applications or registrations, a "Submit to ORS" button will appear on the right side of the Safety Forms page. Clicking the "Submit to ORS" button will lock the form and transmit the data to ORS. You may make changes up to that point. ORS will review your data and contact you with any questions or corrections.

Can I designate someone else do ISIS data entry for me? I am busy conducting my research, writing proposals, attending committee meetings, teaching, and running my laboratory.

Principal Investigators have 3 key responsibilities that cannot be delegated. First, PIs must establish themselves in ISIS and do the initial data entry. Initial data entry means entering ISIS for the first time and completing the first wizard that collects information about the type of work performed in the lab. Subsequent to initial data entry, a safety designate may be assigned to enter the more detailed data that ISIS will request based on the PI's initial data entry. The safety designate then may maintain the data in ISIS. The second PI responsibility is to certify the information in ISIS; most ISIS sections contain statements that the PI is required to confirm as true. Third, PIs are responsible for determining when the data set is complete and ready for "submission." A PI may designate a single proxy who will do ISIS entry. No more than 1 proxy at a time is allowed. If a PI wishes to change proxies (if someone leaves, say, or work assignments change), a user tool is provided for that purpose.

How do laboratory workers fit in? Previously, they had to review and sign Safety Plans.

All laboratory workers listed by the investigator must enter ISIS and review the data. ISIS is intended to be an educational tool as well as a compliance tool. Some sections, such as the bloodborne pathogens section and the radioactive materials section, require documentation of worker awareness and understanding. ISIS ultimately will allow the creation of such documentation.

Some selections are "grayed out" when laboratory workers review ISIS. Why is that?

Because only the PI or the PI's safety designate can change information in ISIS, selections may be "grayed out" during lab worker review to prevent them from changing the data that was entered by the PI or the safety designate.

Once I have completed data entry in ISIS, when will my Laboratory Annual Review take place?

In most cases, ORS will schedule your LAR to take place within 60 days of the start date for your cohort. LARs may be scheduled at a later date in certain situations, such as when an investigator enters ISIS ahead of schedule.

I submitted an application or registration on paper within the last year. Do I have to do it again in ISIS?

Yes, but you may not need to print and submit a form (see the question on printing and submitting forms). The ISIS roll out concept requires each investigator to populate ISIS during the one-year roll out cycle, and only investigators can populate their own data set. This means that for the roll out cycle only, investigators may have to enter the same data that they recently completed on paper. The length of time that will elapse between a PI's having completed a paper form and entering the same data into ISIS will therefore vary from one month to 12 months, depending on a PI's start date in the roll out cycle. However, in general, after the PI populates the data set in ISIS the first time, the investigator "owns" it and all that is required is for the investigator to see that it is updated and maintained.

I may need to submit an application or registration, but my ISIS start date is months away; what do I do?

New investigators, and investigators who need to submit a new application or registration prior to their start date in ISIS, will be allowed to "jump the line" for that purpose. Suppose you are an investigator whose new line of inquiry requires submission of a new recombinant DNA registration, but your formal ISIS entry date is months away. You will be allowed to enter ISIS for the purpose of completing the registration. You will have to enter all of the basic information and proceed through the complete question set of the evaluation wizard before completing the registration. A status page will display an "incomplete" notice for other parts of ISIS until you finish all of the data entry for those parts at a later date. The Laboratory Annual Review may not take place until after you complete all ISIS data entry according to the formal schedule. At ORS's discretion (based on the availability of resources) an investigator who "jumps the line" may be allowed to complete all ISIS sections ahead of schedule.

What ISIS forms (excluding radiation, see below) will I need to print, sign, and send to ORS?

During the first year, registration and committee approval processes will not be automated. PIs will need to print, sign, and send a limited number of forms to ORS. The forms and the circumstances under which they need to be printed, signed, and sent include the following:

• Recombinant DNA Registration: All investigators will re-register their recombinant DNA projects during the first year of ISIS roll-out. All investigators who register must print, sign, and send their registration forms following data review by and consultation with the Biological Safety Professional.
• Exempt Select Agent Toxin Registration: An investigator, who has never before submitted an Exempt Select Agent Toxin Registration either under the old system or in ISIS, must print, sign, and send the registration form following data review by and consultation with the Biological Safety Professional.
• Laser Registration: An investigator, who has never before submitted a Laser Registration either under the old system or in ISIS, must print, sign, and send the registration form to the Laser Safety Officer.

What radiation forms will I need to print, sign, and send to ORS?

During the first year, registration and committee approval processes will not be automated. PIs will need to print, sign, and send a limited number of forms to ORS. The forms and the circumstances under which they need to be printed, signed, and sent include the following:

• Recombinant DNA Registration: All investigators will re-register their recombinant DNA projects during the first year of ISIS roll-out. All investigators who register must print, sign, and send their registration forms following data review by and consultation with the Biological Safety Professional.
• Exempt Select Agent Toxin Registration: An investigator, who has never before submitted an Exempt Select Agent Toxin Registration either under the old system or in ISIS, must print, sign, and send the registration form following data review by and consultation with the Biological Safety Professional.
• Laser Registration: An investigator, who has never before submitted a Laser Registration either under the old system or in ISIS, must print, sign, and send the registration form to the Laser Safety Officer.

I have submitted a protocol to ACUC, however I see that ISIS covers animal research. Am I being forced to duplicate something?

The ISIS focus is on protection of people, while ACUC is primarily concerned with animal welfare. ISIS includes a limited question set that asks for information about zoonoses, hazardous biological agents, anesthetic gases, and chemicals that are present or used in animal research. ISIS does not replace the protocol submission process required by ACUC.