Frequently Asked Questions

Following are questions that frequently arise from staff, faculty, and students:

	Screening Procedures Do general screening tools need HAC approval in order to screen for multiple studies?   If subjects fail a phone screen for one study, can we keep their information and contact them for future studies   Should a screening consent document explain the whole study in detail or should information be limited to the screening visit only?
top	Photographic Release Is a MCG or a MCGHI photographic release required in addition to the informed consent document (ICD)?
top	Consent Documents Does the parent / guardian signature line need to be included on the ICD for studies that includes adult subjects only?   Which letterhead should be used for the consent and assent documents for studies at the CMC?   If changes are made to an ICD between subject visits, resulting in two approved consent forms, is it necessary for the subject to sign both consents or only the most recent version? Which ICDs should be filed in the medical record?   Our subjects will be children, ages 6-17, and adults ages 18-40.  Which consent do we use?   What should the subjects sign when they turn 18 if they had been enrolled as minors?
top	Advertisements Once the HAC approves our advertisement, do we send it to Graphics?   If HAC approved ads will be posted on bulletin boards on and off campus, should the copy with the HAC approval stamp be posted?   Can an ad approved for a previous study be re-used for another study without re-approval from the HAC?   This is a national ad campaign that can't be changed.  Does it still need HAC approval?
top	CVs, Resumes Does the HAC require CVs for sub-investigators that are not affiliated with MCG?   If a protocol was submitted last month along with copies of the applicable CVs, should the CVs be submitted again this month?
top	HAC Form 100 Clinical Study Document Cover Sheet When is the HAC Form 100, Cover Sheet, required?
top	HAC Form 104 Research Medication Data Sheet Is the HAC Form 104 Research Medication Data Sheet required for approved drugs or only investigational drugs?
top	HAC Form 107 Clinical Study Continuation Request Why is the HAC Form 107 Clinical Study Status Report needed?   Why are Continuations given an early deadline for a study that is not due for review until later in the month   What happens if the completed Continuation (HAC Form 107) cannot be sent to the HAC office by the due date   For studies that don’t have a specified number of subjects in the protocol or contract, what should be reported on the Continuation form?   On the Continuation form, what should be entered in the Protocol Prior/New and Extension Prior/New sections   How should subjects that are lost to follow-up be reported on the Continuation form?   This study doesn’t have a screening log of patients.  What should be entered on the Continuation form in this section?   When can I expect my approval letter for the continuation?   Why are consent documents reviewed and approved at the continuing review time for the study?
top	Use of Medical Records and Protected Health Information for Research Where can the HAC policy regarding use of medical records for research be found?   Can patient’s medical records be sent to national registries without HAC approval?   I just want to go look at some medical records to see if a study may be useful.  That’s okay, right?   These medical records are for my patients so I can look through them for research, right?   A benchmarking survey in which we are participating has requested medical records be faxed to them.  That's okay, right?
top	When Is HAC Approval Required? If I want to publish educational methods that were used with students but not done as 'research', is HAC approval required first?   Would pre-approval be necessary to write a description of our departmental orientation program and mention of student satisfaction?
top	Addressing Sponsor Requests Can a sponsor be given patient information for patients that are not in this sponsor's study?   The sponsor has requested that the protocol date be listed on the HAC approval letter, which is not included currently. How can a revised letter be obtained?
top	Storage of Study Records How long do study records need to be stored following study closure?
top	Amendments Can an amendment for dosing changes be approved by expedited review?   If the sponsor sends the site an administrative amendment for a terminated study, does the HAC need that information also   Where can I find the HAC Policy on submitting amendments?
top	AE Reporting How can we verify if all the adverse events for this study have been submitted?
top	HAC Administration  Can I come to the HAC meeting?   Why do so many copies have to be submitted for full Committee review?
top	Subject Becomes Incarcerated, Now What? One of our currently enrolled research subjects is now in jail.  Can we continue them in the study?
top	Federal Wide Assurance, Registration of IRBs What is a Federal Wide Assurance (FWA)?   What is an "Assurance" and When is an "Assurance" Needed?   Why is an IRB or IEC registered?
top	Educational Requirements Why Is the Web-Based Educational Program Required?   How Is The CITI  Individualized To My Needs?   Who Completes Which Learner Groups of the CITI Program?   Do I Need To Complete Additional Sections Of CITI If My Role Or Responsibilities Change?   How Long Will It Take To Complete The CITI Program   Can I Be Approved To Do Research Before I Complete CITI?   Can I Collect Data Or Review Medical Records Before I Complete CITI?   What Are The Recertification Requirements for CITI?   Are Continuing Education Credits (CEU) Available for CITI?   How Do I Change My Registration for CITI?
top	Do general screening tools need HAC approval in order to screen for multiple studies? Basic screening tools that ask general health information (height, weight, diet, sleep patterns, exercise history, etc.) can be used to screen for multiple studies without HAC approval. However, screening tools will need HAC approval if vulnerable populations are screened or if sensitive information is sought about the subject, his / her family members, employers, or household members such as: Protected Health Information including diagnosis, medical / surgical history including history of mental illness or infectious disease, current medicine regimen, etc. Personal information that may have legal repercussions (history of DUI, criminal activities, use of illegal substances, history of domestic violence, etc. ) Other potentially embarrassing personal information (sexual practices, deviant behaviors, financial history, employment history, etc.). Please note the above lists and examples are not all inclusive.
top	If subjects fail a phone screen for one study, can we keep their information and contact them for future studies? No subject information may be kept unless the subject provides written approval to do so. Mail the subject a consent form, which the subject must sign, date, and return to the site. The consent form must state the purpose of retaining the information (i.e. to contact about future studies) and detail exactly what information will be retained (i.e. name, phone number, etc.).  However, such consent forms will need HAC approval before use if the subject is a member of a vulnerable population or if sensitive information is intended to be kept about the subject, his / her family members, employers, or household members such as: Protected Health Information including diagnosis, medical/surgical history including history of mental illness or infectious disease, current medicine regimen, etc. Personal information that may have legal repercussions (history of DUI, criminal activities, use of illegal substances, history of domestic violence, etc. ) Other potentially embarrassing personal information (sexual practices, deviant behaviors, financial history, employment history, etc.). Please note the above lists and examples are not all inclusive.
top	Should a screening consent document explain the whole study in detail or should information be limited to the screening visit only? Provide a brief description of the study and include the risks, benefits, etc. associated with the screening visit only.
top	Is a MCG or a MCGHI photographic release required in addition to the ICD? The HAC-approved informed consent document includes information about taking a picture of the subject’s wound with no identifiers? As long as the consent clearly states what will be done with photos and how  confidentiality is maintained, no other form is necessary.
top	Does the parent / guardian signature line need to be included on the informed consent document for studies that include adult subjects only? No.
top	Which letterhead should be used for the consent and assent documents for studies at the CMC?  The CMC letterhead is the preferred choice; however, the MCG seal may be placed on non-letterhead paper, if the investigator so chooses.
top	If changes are made to an ICD between subject visits, resulting in two approved consent forms, is it necessary for the subject to sign both consents or only the most recent version? Which ICDs should be filed in the medical record? For example: a subject is scheduled for visits 5 and 6, which are six months apart, and the protocol is revised after visit 5, which requires a revised ICD. Then, one month before visit 6, the ICD is revised a second time and approved. The subject should sign the most recent ICD, as long as it contains all the information from previous revisions. Copies of each signed informed consent document must be in the medical record and/or source document.
top	Our subjects will be children, ages 6-17, and adults ages 18-40.  Which consent do we use? For the children, the HAC recommends a children's assent document, 6-12, and another for children ages 13-17.  Their parent and/or guardian must sign a parental ICD.  The adult subject must sign an adult ICD.
top	What should the subjects sign when they turn 18 if they had been enrolled as minors? We have subjects who will be followed from ages 13 to 40. We will have them sign a children's assent document when they are under 18 and have their parent sign a parental informed consent document.   Have them sign an adult ICD.
top	Once the HAC approves our advertisement, do we send it to Graphics? No.  The HAC approval includes Graphics’ approval.
top	If HAC approved ads will be posted on bulletin boards on and off campus, should the copy with the HAC approval stamp be posted? Yes.
top	Can an ad approved for a previous study be re-used for another study without re-approval from the HAC?   No.  Each ad has to be submitted to the HAC.
top	This is a national ad campaign that can't be changed.  Does it still need HAC approval? Yes.
top	Does the HAC require CVs for sub-investigators that are not affiliated with MCG?   No.  Only those investigators with MCG, MCGHI, or VAMC affiliations need to submit their CV or resume.
top	If a protocol was submitted last month along with copies of the applicable CVs, should the CVs be submitted again this month? No.  The investigator’s CV must be updated and forwarded to the HAC on an annual basis.  If you are unsure if the HAC has an up-to-date CV, call the HAC office ( 706-721-3110 or 706-721-1482) and ask if one is on file.  Only one copy of a current CV should submitted on an annual basis.
top	When is the HAC Form 100, Cover Sheet, required to be submitted? The HAC Form 100 is only required with the HAC Form 101, Form 101C, Form 103, Form 104, Form 105, Form 106, and Form 108.
top	Is the HAC Form 104 Research Medication Data Sheet required for approved drugs or only investigational drugs? Our study will use an FDA approved drug and a non-approved investigational drug.  The Investigational Pharmacist recommends completing an HAC Form 104 for the investigational drug; note on the form under the instructions/misc section that other approved drug(s) will be part of the regimen.  Provide copies of investigational drug brochures and/or package inserts as available.  If the study is blinded, submit a HAC Form 104 for all drugs.  An approved drug is still a research drug if used in a research study.
top	Why is the HAC Form 107 Clinical Study Status Report needed? FDA, OHRP, and institutional policies require that all research be reviewed at least annually or more frequently depending on the risk assessment.
top	Why are Continuations given an early deadline for a study that is not due for review until later in the month? Continuations must be approved at the monthly meeting. HAC now requires that the completed forms be submitted by the due date noted on the form in an effort to avoid unnecessary termination.
top	What happens if the completed Continuation (HAC Form 107) cannot be sent to the HAC office by the due date? Fax a copy and then send the original via campus mail.  Call the HAC administrative office at 706-721-3110 or 706-721-1482 and provide a date that the original form will be received by the HAC office.  These continuations must be presented to the full committee and have to be added to the meeting agenda prior to the meeting. There is no grace period.
top	For studies that don’t have a specified number of subjects in the protocol or contract, what should be reported on the Continuation? Put an asterisk in the box and explain in the "comments" section.
top	On the Continuation form, what should be entered in the Protocol Prior / New and Extension Prior / New sections? If this is the first Clinical Study Status Report form that was completed for the study, then leave the Protocol Prior section blank and enter the numbers on the Protocol New section.  If an annual report was submitted to the HAC since 10/97, then the Protocol Prior section should be completed by our computer program using the numbers that were given to us on those previously submitted forms. If there is an HAC approved multiple extension protocol and adequate room to include all of the information is lacking on the form, then attach the applicable information and numbers to the Continuation form.
top	How should subjects that are lost to follow-up be reported on the Continuation form ? These subjects are in oncology studies and are followed for life. These subjects should be counted as dropped/withdrawn/screen failure. Please indicate lost to follow up in the comments section on page two. Such subjects are only complete on these protocols when they expire or relapse at which time they are usually approached with another protocol.
top	This study doesn’t have a screening log of patients.  What should be entered on the Continuation form in this section? Start a screening log.  This log helps the study site in many ways: tracks numbers of patients screened to see if they might fit another protocol, helps justify the time spent on studies, etc.  The FDA likes screening logs!  If a screening log is not kept, enter unknown.
top	When can I expect my approval letter for the continuation? The meetings are the fourth Monday of each month, unless otherwise designated.  The letters should go out via campus mail, no later than the Monday following the meeting.
top	Why are consent documents (i.e. ICD, children’s assent document, etc.) reviewed and approved at the continuing review time for the study? As part of the continuing review as outlined by the Food and Drug Administration (FDA) and the Office for Human Research Protections (OHRP), each protocol must be reviewed and approved by the IRB.  Each ICD and/or CAD will be reviewed and stamped approved as appropriate.
top	Where can the HAC policy regarding use of medical records for research be found? Please refer to HAC Policy (Section 43): HIPAA and Databases, Medical Records Review and Collection of PHI.
top	Can patient’s medical records be sent to national registries without HAC approval? No.
top	I just want to go look at some medical records to see if a study may be useful.  That’s okay, right? No. These patients are not your HAC approved research subjects. The only records that you may review are your own patients. Each chart review requires a submission to the HAC to determine the appropriate level of review: exempt from full board review, expedited, or full review. The Committee makes the final review level decision.
top	These medical records are for my patients so I can look through them for research, right? No.  These are the medical records for your medical patients; they are not your HAC approved research subjects.
top	A benchmarking survey in which we are participating has requested medical records be faxed to them. That's okay, right? No.  This is research, and no medical records may be sent offsite without completely anonymizing the record.
top	If I want to publish educational methods that were used with students but not done as 'research', is HAC approval required first? These educational methods were used in class --not "researched" per se.  The methods were developed and then used  in class. Students gave feedback in the form of regular course or instructor evaluations - would that require HAC approval beforehand? It fits the definition of research as "generalizable knowledge".  Present the study to HAC for exempt review.  Quite a few journals are now requiring IRB approval prior to publishing. This study sounds like it would fit under exempt review as one of the following: Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.   Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects;  Research, involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. I believe that the key here would be to avoid using identifiers to link students to their answers. Course evaluations are presumed to be anonymous.
top	Would pre-approval be necessary to write a description of our departmental orientation program and mention of student satisfaction on the exit survey (again, a standard program requirement, not a special "research" addition)? This study does not require HAC submission because all three of the following requirements are met: 1) the study won't be published for "generalizable knowledge"; 2) the survey doesn't have any identifiers, and 3) the study will only be used for internal (on our campus) quality improvement methods.
top	Can a sponsor be given patient information for patients that are not in this sponsor's study? If the sponsor is requesting patient data, then the investigator should submit a protocol to the HAC for approval.  If no identifiers are to be used, it will probably qualify as an Exempt from Full Review protocol.  If identifiers are to be used, then informed consent must be obtained.
top	How long do study records need to be stored following study closure? Our study has been over for about three years.  How long do we have to store this stuff? Per FDA 21 CFR312.62 Investigator record keeping and record retention: Disposition of drug Case histories.  An investigator is required to prepare and maintain adequate and accurate case histories designed to record all observations and other data pertinent to the investigation on each individual treated with the investigational drug or employed as a control in the investigation. Record retention.  An investigator shall retain records required to be maintained under this part for a period of 2 years following the date a marketing application is approved for the drug for the indication for which it is being investigated; or, if no application is to be filed or if the application is not approved for such indication, until 2 years after the investigation is discontinued and FDA is notified. Per ICH Guidelines 4.9 Records and Reports, Section 4.9.5:     a.   Essential documents should be retained until at least 2 years after the last approval of a marketing application in an ICH region and until there are no pending or contemplated marketing application in an ICH region at least 2 years have elapsed since the formal discontinuation of clinical development of the investigational product.  These documents should be retained for a longer period, however, if required by the applicable regulatory requirements or by an agreement with the sponsor.  It is the responsibility of the sponsor to inform the investigator/institution as to when these documents no longer need to be retained (see section 5.5.12). Contact the sponsor and ask if they can store the documents after the two-year obligation is met.  Some will store the information or they will provide written documentation to destroy the records. We currently have no policy on record retention, other than the FDA regulation.  We are in the process of preparing a SOP for this.  As far as budgetary information, this is an investigator decision. The CFR regulations only apply to those studies under FDA jurisdiction.
top	Can an amendment for dosing changes be approved by expedited review? No. The only amendments that can be approved by expedited review are those that are administrative in nature or if the study was approved originally by expedited review and the Chairman feels that the changes are no greater than minimal risk.
top	If the sponsor sends the site an administrative amendment for a terminated study, does the HAC need that information also? Yes.
top	Where can I find the HAC Policy on submitting amendments?  Please refer to the HAC Policy (Section 14): Protocol Amendments.
top	The sponsor has requested that the protocol date be listed on the HAC approval letter, which is not included currently. How can a revised letter be obtained? Submit a request in writing for a corrected letter.
top	How can we verify if all the adverse events for this study have been submitted? My monitor is coming and I need help! Contact the HAC office at 706-721-3110 or 706-721-1482 or via email (hac@mcg.edu), (mailto:chucksam@mail.mcg.edu or mailto:swilling@mail.mcg.edu) and request a copy of the serious adverse event log printout.  The printout may be mailed intercampus, faxed or email.  Please allow at least 48 hours for this request.
top	Can I come to the HAC meeting? Absolutely!  They are held the fourth Monday of each month in the Interdisciplinary Research Building Phase II (CA-2105) at 12:00 p.m..  However, you must contact the HAC office by the Wednesday prior to the meeting.
top	Why do so many copies (original plus four and then an additional numbers of copies) have to be submitted for full Committee review? In order to remain compliant with current Office for Human Research Protections (OHRP) and the United States Food and Drug Administration (FDA) rules and regulations, the proposed research must be available for review by each member of the institutional review board (IRB).
top	One of our currently enrolled research subjects is now in jail.  Can we continue them in the study? They gave consent and started the trial prior to their incarceration.  If the HAC approved protocol does not address the issue of prisoners as research subjects, then the subject must be withdrawn from the trial. According to Federal regulations, any research that involves prisoners in any manner must have specific approval for their participation. Additional protections specific to prisoners must be included in the protocol because prisoners are a vulnerable population.  The definition of a prisoner is as follows: An individual involuntarily confined in a penal institution, including persons: 1) sentenced under a criminal or civil statute; 2) detained pending arraignment, trial or sentencing; and 3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment  procedures providing such alternatives to criminal prosecution or incarceration in a penal institution.
top	What is a Federal Wide Assurance (FWA)? Under the Department of Health and Human Services (DHHS) human subjects protection regulations at 45 C.F.R. 46.103, every institution engaged in human subjects research supported or conducted by DHHS must obtain an assurance of compliance approved by the Office for Human Research Protections (OHRP). Historically, OHRP has approved three basic types of assurances: Multiple Project Assurance (MPA), Cooperative Project Assurance (CPA), and Single Project Assurance (SPA).  All MPAs approved by OHRP were designated for federal-wide use. In December 2000, OHRP developed an Institutional Review Board (IRB) Registration and a new Federalwide Assurance (FWA) intended to: 1) create a new registry of IRBs, and 2) streamline the assurance process to significantly reduce the administrative burden on individual institutions, other federal departments and agencies, and OHRP.
top	What is an "Assurance" and When is an "Assurance" Needed? The Federal Policy (Common Rule) for the protection of human subjects at Section 103(a) requires that each institution "engaged" in Federally-supported human subject research file an "Assurance" of protection for human subjects. The Assurance formalizes the institution’s commitment to protect human subjects. The requirement to file an Assurance includes both "awardee" and collaborating "performance site" institutions. Under the Federal Policy (Common Rule) at Section 102(f) awardees and their collaborating institutions become "engaged" in human subject research whenever their employees or agents (i) intervene or interact with living individuals for research purposes; or (ii) obtain, release, or access individually identifiable private information for research purposes. In addition, awardee institutions are automatically considered to be "engaged" in human subject research whenever they receive a direct HHS award to support such research, even where all activities involving human subjects are carried out by a subcontractor or collaborator. In such cases, the awardee institution bears ultimate responsibility for protecting human subjects under the award. The awardee is also responsible for ensuring that all collaborating institutions engaged in the research hold an OHRP approved Assurance prior to their initiation of the research. FEDERAL WIDE ASSURANCE (FWA) NUMBER Institution Name Details Medical College of Georgia (MCG) Detail FWA00002245 Medical College of Georgia Research Institute (MCGRI) Detail FWA00002246 Medical College of Georgia Health, Incorporated (MCGHI) Detail FWA00002534 VAMC – Augusta Detail FWA00002260 Augusta Biomedical Research Corporation (ABRC) Detail
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	Why is an IRB or IEC registered? Registration will facilitate DHHS’s effort to establish effective communication with IRBs and IECs working to protect human subjects, especially those responsible for HHS-regulated or HHS-supported research. Registered IRBs will benefit from emerging technologies to make communication to and from HHS quick and easy. At the present time, Registration is required only for IRBs and IECs designated under an OHRP Federalwide Assurance of Protection for Human Subjects. However, other IRBs and IECs are encouraged to register voluntarily. IRB Registration is not currently required by FDA. INSTITUTIONAL REVIEW BOARD (IRB) REGISTRATION INFORMATION IRB REGISTRATION NUMBER INSTITUTION NAME DETAIL IRB00000150 Medical College of Georgia (MCG) IRB #1 Detail
top	Why Is the Web-Based Educational Program Required?  The Medical College of Georgia requires all individuals who have a formal affiliation with MCG (faculty including adjunct faculty, staff, students, or others with a formal affiliation with MCG) participating in research (investigators, coordinators, basic scientists, data managers, administrative personnel, or any one else involved in data collection, data management, or interactions with subjects or materials derived from subjects) involving human subjects or human derived materials to successfully complete the educational program CITI at the appropriate learning group prior to initiating any research activities.  The MCG educational program is available to MCG-affiliated individuals only. Investigators affiliated with institutions other than MCG should complete the applicable human subject protection education and research training programs as required by their institutions; certificates of completion from such educational programs will be accepted by MCG for outside investigators.
top	How Is The CITI Individualized to my needs? CITI consist of modules specified for each Learner Group that focus on a different aspect of bio-ethics and human subjects research.  The curriculum for each Learner Group was customized by our institution to meet the specific education needs of our researchers. MCG CITI Learner Groups: FDA Regulated Studies:  Drugs, Devices and Biologics Human Derived Materials Studies: Medical records, specimens, genetics or reproductive materials, databanks, registries Non-FDA Regulated Studies: Investigator-initiated studies, prevention studies, community-based research Social and Behavioral Research: Surveys, questionnaires, interviews, photography, tape recordings VA Research: Required for researchers who conduct any of their studies at the VA Office of Human Research Protection (OHRP) Staff Human Assurance Committee (HAC) members
top	Who Completes Which Learner Groups of CITI Researchers will choose the Learner Group specific to their research area.  If a researcher conducts research involved in more than 1 Learner Group, they should contact Kim Koss, Training Coordinator, 1-1481 kkoss@mcg.edu for guidance.
top	If my Research Area Changes Do I Need To Complete Additional Learner Groups of CITI There are instances when your research area may change and certification in your initial Learner Group is no longer sufficient.   For instance, a researcher initially conducted behavioral studies (i.e. completed the Social and Behavioral Research Learner Group) and later wishes to conduct FDA regulated studies.  Completion of additional modules are required before conducting FDA regulated research.  If your research area changes, contact Kim Koss, Training Coordinator, 1-1481 kkoss@mcg.edu for guidance.
top	How Long Will It Take To Complete CITI? On average it will take about 4-6 hours to complete the “Basic Course”.   Users can complete the Course in as many sessions as needed.
top	Can I Be Approved To Do Research Before I Complete The Web-Based Educational Program? No. Protocol approval or continuation of a current study will not be granted until all research staff members have completed the appropriate tiers of the program. New sub-investigators will not be approved unless they have completed the educational program. If you will be assuming additional duties that require completion of a higher tier, then you must complete the additional education before assuming these additional duties.
top	Can I Collect Data Or Review Medical Records Before I Complete The Web-Based Educational Program? No. Data collection and medical record review is permissible until all HAC requirements, including completion of the educational program, have been met. The study must be amended to add any new investigator(s) who may not participate in clinical research activities until formal written approval to do so has been granted by the HAC, which is not equivalent to completion of the educational program.  In some circumstances, the addition of new sub-investigators may require full IRB review as outlined in the HAC policies: Protocol Amendments.
top	What Are The Recertification Requirements For CITI? Recertification is required every 3 years after initial certification.  As of July 1, 2005 researchers must take the Basic Course for your Learner Group for recertification.  After this, you are only required to complete the “Refresher Course” for recertification.
top	Are Continuing Education Credits (CEU) Available For CITI? Yes.  CITI will provide links to apply for CME/CEU credits through the University of Miami CME office.
top	How Do I Change My Registration Or Get Access To Other Modules Of The Web-Based Educational Program? Contact Kim Koss, Training Coordinator, 1-1481 kkoss@mcg.edu for guidance.