1. REGULATORY MANAGEMENT
JUNE 2012
REGULATORY MANAGEMENT
Marie D’Amico, GRACP, CCRP
Manager, RTOG Regulatory Affairs

2. Disclaimer
The following presentation is being given for RTOG studies only.  The information represented here while current may change due to changes within RTOG internal processes or because of federal regulatory guidelines.  Therefore, you may not reproduce or distribute any of the presentation without obtaining RTOG’s prior written consent.

3. Discussion Points Regulatory Documents & the CTSU
Drug Procurement & Accountability
RTOG SAE Safety Reporting
Site initiated Internal SAE Reporting
Pharmaceutical/NCI initiated External Safety Reports

4. Regulatory Documents & the CTSU
JUNE 2012
Regulatory Documents & the CTSU

5. Regulatory Documents All regulatory documents for US, Canadian &
Non North American sites are submitted to the
CTSU for cataloguing and data entry
Continuing Reviews
Approvals of amendments
IRB initial study approvals
IRB approved consent forms
(translation required for Non English speaking countries/provinces)

6. Continuing IRB Approval
IRB approval must continue until
Finite Studies
All subjects accrued have completed treatment and follow up
Non Finite Studies
All subjects are deceased
Additional requirements for both finite & non finite studies
No further accrual is anticipated
All data forms have been submitted
All queries to date have been resolved
RTOG approves the site for early closure (see form)
IRB approval remains necessary, even after RTOG study closure and until RTOG termination unless all the above criteria/requirements have been met
Only RTOG can classify a study as "terminated" (Database locked)
Notification of Study Termination will be received via broadcast
A formal request is required for early closure when all criteria met

7. Form to Request Early IRB Closure http://www. rtog

8. Requests for Early IRB Closure
Request form must be submitted to and approved by RTOG
The Form has Multiple purposes
Request consideration for early closure with IRB
Request closure with IRB when no patients enrolled on study
Transfer IRB responsibilities
RTOG response with approval of the request is required prior to taking any closure action
Internal multi department review at RTOG HQ can take 7-10 business days to complete
Sites will still be required to respond to queries even after study closure with the IRB

9. Continuing IRB Approval
IMPORTANT NOTE Full member institutions that have affiliates that use the Full Member IRB as their IRB of record must ensure that those affiliate/ Joint Center institutions had also never put any patients on studies they are considering closing with the IRB. If they have, then the main IRB must keep this study open for annual review.

10. Special Handling
Handling of all other study specific regulatory documentation is detailed in Sections 5.0 or 7.0 of the protocol
Study Agent Shipment Form (SASF)
Sponsor required documentation
Questionnaires
Training Certifications
RT Certifications
Non English speaking Canadian & Non North American sites are required to supply the Certified/Verified English translation and native language copy of the IC with their regulatory approvals
Other special procedures may exist for Non North American sites

11. Correlative Components
Each participating institution must be prepared to participate in all correlative components/have a plan in place to facilitate participation and must offer every patient the opportunity to participate in these components.
ONLY THE PATIENT can decline to participate in the correlative components of a study
The majority of RTOG studies require varying degrees of specimen collection as part of eligibility, stratification or protocol treatment.
Sites are encouraged to become more organized in their efforts and coordinate tissue banking collections with other protocol required specimen collections whenever possible.
In the event tissue is collected/residing at another facility RTOG expects a good faith effort to obtain the retrospective specimens but the site will not be penalized if it is not possible.
Prospectively the site must inform the collecting entity that future specimens collected are expected to be forwarded along with the appropriate submission form for tissue banking as noted in the protocol.

12. CTSU Forms & Guidance Can be found on the RTOG website www.rtog.org
under RA/Regulatory Info/CTSU Filing Requirements
IRB Certification Forms
310 Certification Form
IRB Transmittal Forms
Guidance for completing the forms
RSS Flow sheet
NCI Required Forms are also available here
FDA 1572
CTEP Supplemental Investigator Data Form (IDF)
CTEP Financial Disclosure

13. Proper Labeling Ensures Proper Processing
Please identify all information submitted to the CTSU with the institution’s NCI Code on the transmittal/certification form
If the submission covers more than one institution or an entire CCOP all assigned individual NCI institution codes covered under the approval must be listed on the transmittal/certification form or supplemental page

14. CTSU Forms Transmittal/Certification

15. Resolving Regulatory Issues
All issues for U.S., Canadian and Non North American sites with submitted regulatory documents should be handled directly through the CTSU.
RTOG does not have access to copies of regulatory documents that have been submitted to the CTSU.

16. Checking Registration Status
Visit the CTSU Website:
Requires a CTSU username & password
Sites are identified by NCI Code
Lists all requirements for study
Lists items not in compliance
Now available for Non North American sites

17. To obtain a CTSU password…

18. Points of Contact for the CTSU
Help Desk:
Regulatory Help Desk: CTSU (2878)
for questions:
For Regulatory Submissions:
Fax Number:
Mailing Address: 
CTSU Regulatory Office
Coalition of National Cancer Cooperative Groups
1818 Market Street, Suite 1100
Philadelphia, PA
Website:

19. Record Retention According to the NCI Investigator Handbook:
10.3 Retention of Records
FDA regulations require that all research records (including patient
charts, case report forms, x-rays and scans that document response, IRB approvals,
signed informed consent documents and all agent accountability records)
must be kept by the investigator for at least 2 years after an NDA or BLA has
been approved for that indication or the CTEP IND has been closed. CTEP
will notify investigators when these events occur. This requirement is an
explicit part of the FDA Form 1572,
For NON IND Studies:
The point of reference used to determine the length of time required for record
retention for non IND studies would be RTOG’s termination date for the study,
which is when the database is locked and no further information would be required.
The recommended timeframe for record retention is 3 years past termination
The institution’s (and IRB’s) guidelines would also need to be considered.

20. Password Protected Documents on the RTOG Website
An RTOG user name and password may be required to gain access to some password protected documents
The username and password used for web registration will permit access to these documents
The application to obtain a username & password is now web based. Paper submissions will no linger be accepted. Complete the online application at the following link:
The usual turnaround time for password authorization requests is two business days

21. Informed Consent Concerns
RTOG provides an NCI and ACR IRB Approved consent template for each protocol
RTOG prefers no changes be made other than to add local context
IRB requested additions to the document for clarity are permitted
The Deletion of any information should be avoided to preserve the integrity of the document
The essential elements of the RTOG Informed Consent Template must remain intact
IRB required deletions of risks and alternative procedures will require written justification
Please refer to RTOG Guidance Document for making changes to the informed consent template (revised 5/2010)

22. Informed Consent Approval
It remains your IRB’s responsibility to review and approve the informed consent content and any changes made at the site level
A CERTFIED or VERIFIED English & native language translation of the IC is required for Non English speaking Canadian & Non North American sites
Please note the RTOG Regulatory Compliance Department does not review consents. All consent content will be reviewed at time of audit.
Problems and deficiencies with IRB approved consents found during the audit will be reported as appropriate.

23. Broadcasts & Summary of Changes
Information relating to protocol updates and amendments can be found on the RTOG web site:
RTOG suggest sites check the website regularly to assure they have received all broadcast information
NCI requires that cooperative groups provide a Summary of Changes which describes the changes made to a protocol, and indicates whether the changes are administrative (update) or treatment related (amendment)
On the website select Clinical Trials/Protocol Table, then the protocol number:
Select “Summary of Changes” under Protocol Documents scroll through the document to see all previous
Select “Broadcasts”, from left column, a list of protocol specific broadcasts will open.

24. Finding Broadcasts & Amendments On The Website

25. Protocol Updates
Updates are editorial/administrative changes that RTOG is allowed to make without prior NCI approval (updates are sent to NCI for their information).
Examples of protocol updates might include:
correction of typos
changes/additions to administrative processes
change in the address for data submission
change in a Co-Chair’s contact information.
Per NCI, an update cannot involve patient treatment or anything that would impact patient safety.
The RTOG broadcasts indicate “IRB review of an update is not required; however, these changes must be reported to the site IRB”

26. Protocol Amendments
All treatment or safety related changes to protocols are amendments,
Amendments are sent by RTOG to NCI for review and approval.
As “Per CTMB Guidelines, amendments must be reviewed and approved by local IRBs within 90 days.
For Canadian sites the broadcast of Health Canada’s approval of the amendment begins the 90 day timeframe

27. Drug Procurement & Accountability
JUNE 2012
Drug Procurement & Accountability

28. Possible Sources of Drug Supply
Pharmaceutical Companies
Third Party Distributor
NCI-Pharmaceutical Management Branch (PMB)
Commercially available products
* More than one may apply in certain studies.

29. Canadian Review Board (CRB)
Purpose: To identify barriers, specifically related to drug availability and differing RT standards in the various member provinces early in the development of the protocol when there is the potential to address these issues.
Initiated in April 2009
Representation: a provincial board member from each member province was appointed by the Canadian vice chair.
Please remember to share all drug or RT related protocol concerns with your provincial board member as early as possible.

30. CRB Provincial Representation & Contact Information

31. Important Note About Non North American Sites
Non North American Institutions are advised not to submit a study for approval by their local regulatory body until their participation has been confirmed in the written notice of an approved Letter of Intent (LOI) from RTOG HQ.
All Non North American Institutions must submit an LOI to RTOG HQ indicating their interest in participating in any RTOG Study.
Formal Approval of the LOI will be received via with IMPORTANT specific instructions for moving forward
Once the LOI has been approved, documentation of completion of all applicable regulatory pre-registration requirements as noted in the protocol must be submitted directly to the CTSU before enrollment can begin.

32. Important Note About Non North American Sites
Participation will not be possible if any part of the study specific requirements outlined in the protocol conflict with your country's Ministry of Health regulations.
It is your institution's responsibility to understand and comply with all national Ministry of Health Regulations.
Translation of documents is critical. The cost of all translation would be your institution's responsibility. All regulatory documents, data and supporting documentation (when required) would need to be provided in English with certified/verified translation documentation
Your institution will be responsible for acquiring any drug noted in the protocol as commercially available.
Non North American participation in studies with a drug component will only be permitted if RTOG can procure and provide a supply of the study agent for your region

33. International Letter of Intent (Pages 1& 2 of 3)

34. International Letter of Intent (page 3 of 3) “
International Letter of Intent (page 3 of 3) “****Please review important information attached with response****”.
This portion of the form will be returned to the site by RTOG HQ noting approval or disapproval
A second very important document will also be provided with the approval, entitled International Letter of Intent to Participate Response, outlining expectations and requirements
This document must be retained as a checklist to assure preregistration compliance prior to patient registration/enrollment.

35. Finding International Forms on the Website
International Letter of Intent (LOI)

36. Pharmaceutical Company Supplied Drug Procurement
Procedure can vary by study.
Detailed instructions for obtaining drug can be found in Section 7.0 of each protocol
First step a pre-registration requirement, as noted in Section 5.0, submit the Study Agent Shipment Form (SASF) to CTSU
Processing of this form approves the site as eligible to receive drug
Registration/Randomization is the trigger for the initial shipment

37. SAMPLE (SASF) Study Agent Shipment Form

38. Finding RTOG SASFs On the Website
Clinical Trials/Protocol Table/Select Study/Regulatory Resources

39. Pharmaceutical Company Supplied Drug Procurement
Submitting your SASF for processing as soon as the
individual responsible for the drug at your institution
has been identified will assist you in:
avoiding delays in the initial drug shipment
alleviating frustration and inconvenience for yourself and most importantly the patient

40. Pharmaceutical Company Supplied Drug Procurement
Realistic Treatment Start Dates
If the SASF has already been processed, drug is received much faster, generally for overnight or two day delivery.
Most distributors will not ship prior to a weekend or holiday.
Shipments are generally restricted between December 23 and January 1.
Canadian sites should take into consideration the possibility of customs delays

41. NCI Drug Procurement
The Pharmaceutical Management Branch (PMB) of the NCI is responsible for supplying study agent for studies where the NCI holds the IND.
When the PMB supplies the drug for a study they are also responsible for providing the Investigator Brochure.
On-line Agent Order Processing (OAOP) is now required for PMB provided drug
NIH Form 986/Clinical Drug Request – OBSOLETE
OAOP Training Guide available
All NCI Forms are available on the NCI website at
Investigational Drug Accountability Record Form (DARF)
Drug Return
Drug Transfer

42. Canadian Drug Accountability
There is a PMB approved Canadian Drug Accountability Form, which can be used by Canadian institutions for both PMB and pharmaceutically supplied drug.
This form is available on the RTOG website with the other Canadian resources

43. NCI Drug Procurement
Investigators must be registered with the NCI and have an
Investigator NCI Number to receive drug from the NCI.
Maintenance of this NCI Investigator Number requires the annual
submission of:
FDA 1572 with CVs
signed Supplemental Investigator Data Form (IDF)
Financial Disclosure Form
NCI/PMB Contact Information:
Phone: (301)
Fax: (301)

44. NCI On-Line Drug Procurement

45. NCI On-Line Drug Procurement
The Online Agent Order Processing (OAOP) Training Guide is available from this NCI web page

46. Drug Accountability Record Forms NCI RTOG

47. Finding RTOG Accountability Records on the Website
Clinical Trials/Protocol Table/Select Study/Regulatory Resources

48. Commercially Available Products
Supplied free of charge through pharmaceutical support directly from the pharmaceutical company or via a third party distributor OR
Obtained via prescription from the physician

49. End of Study Drug Disposition
Can vary by sponsor/protocol
Records of accountability documentation may require submission
Receipt of Drug
Dispensation of Drug
Disposition of Drug (returned/destroyed used/unused)
Instructions usually documented in the protocol
Institutional Drug Destruction Policy or SOP
Required for site drug destruction

50. Return/Destruction of Study Drug
When applicable, unexpired, unused, unopened, nontransferable agents remaining after a study has been permanently closed to accrual by RTOG must be returned to the distributor within 90 days of the RTOG closure broadcast.
If end of study drug destruction is noted in the protocol it must be carried out within 90 days of study closure and accountability records must be retained.
If the institution lacks a written policy or SOP pertaining to drug destruction, drug must be returned to the distributor for destruction within 90 days of study closure.

51. Blinded Studies RTOG saw a marked increase it drug errors on blinded
RTOG studies particularly RTOG 0825.
Please take the time to consider the importance of reviewing drug
administration and safety policies with related staff in an effort to
eliminate these errors.
RTOG suggests a double or even triple check of the drug label
and patient ID or a two person check similar to hospital drug
transfusion policies.
Contact RTOG HQ if you would like assistance with training your
research pharmacy or staff.

52. Case & Point
Drug for two cases was received in same box but segregated in separate appropriately labeled plastic bags each containing 2 boxes of vials of drug (one full + one partial box). The boxes were removed from the plastic bag. The full boxes were stored properly per patient identification but there was a crossover with the storage of the partial box. One case received vials from both the partial and full box (the right and wrong TX assignment). This same case also experienced an SAE requiring immediate surgery prior to becoming aware of the drug mix up. Due to the bleeding issues associated with Bev the case was unblinded prior to surgery. The case had been assigned to the placebo Arm of the trial but in reality the unblinding information was inaccurate because the site was unaware at that time of the drug mix up, which placed the case at a much higher risk for complications during the surgery.
Both cases were ultimately removed from protocol TX.

53. Blinded Studies Important Points to remember:
The number of RTOG blinded drug studies is increasing.
The order of the initials entered during registration significantly impacts our ability to quickly unblind a case in an emergency situation
Initials must be entered as First Middle Last (FML) or F-L if there is no middle
The full DOB (MM/DD/YYYY) is also required for all blinded studies to allow us to confirm we have the right patient during unblinding in the event there are cases with the same initials

54. Emergency Unblinding Procedures
“Decisions to break the code will only be considered for life threatening
events or extraordinary clinical circumstances where it can be
demonstrated knowledge of the drug treatment assignment will affect
clinical judgment.”
During RTOG business hours (8:30AM-5PM ET) call RTOG HQ at and ask to speak to a statistician.
After hours (5PM-8:30AM ET) call
Calls received after hours or during weekends and holidays will be returned as soon as possible. Please leave your name, contact information, the first and last name of the patient who experienced the event, the study & case number and the reason for the unblinding request.
If the unblinding request pertains to RTOG 0825 and tumor progression, please contact Treena Trotman at during regular business hours

55. Emergency Unblinding
Requests to unblind either case in the situation of a corruption or crossover in drug administration will likely result in both cases being removed from the study
The Emergency Unblinding line is for true emergencies only
Please do not leave messages pertaining to anything but emergency unblinding
This is NOT a catch all after hours office line
Messages left for any other reason will not be forwarded or receive a response

56. Minimum Required Information for Emergency Unblinding Request
The unblinding officer will contact you for further information.

57. Protocol Deviations
CTEP has a policy in place related to the issuance of waivers for protocol deviations:
The policy applies to all components of CTEP-approved protocols, including eligibility criteria, treatment schedules, dose modifications, toxicity assessment, response criteria, and statistical aspects.
Link to Policy:
CTEP does not issue or approve any waivers for protocol deviations

58. NCI Deviation Policy

59. RTOG SAE Safety Reporting
JUNE 2012
RTOG SAE Safety Reporting

60. Guidelines for AE Reporting
The protocol provides basic instruction regarding adverse events (AE) and Protocol Specific Special Reporting (PSSR).
Those serious adverse events meeting the criteria described in the protocol must be reported via the Adverse Event Expedited Reporting System (AdEERS)
AdEERS related training and guidance is also available from the NCI.

61. Current AdEERS Reporting Pathway (Decentralized) Centralized changes coming soon…

62. Centralized SAE Reporting Coming Soon…

63. RTOG Centralized SAE Review
An SAE Coordinator position has been created at RTOG HQ
To coordinate the timely review of submitted information, perform necessary edits for accuracy & clarity and submit report s of all UNEXPECTED and RELATED SAEs to the NCI, pharmaceutical sponsor and to the FDA as required by regulations.
Timely feedback will be required to meet the regulatory reporting timeline
The site RA should remain alert for requests from the SAE Coordinator in an effort to obtain information to ensure the clarity and accuracy of the SAE report

64. Centralized reporting expectations for the reporter…
As the reporter you will
Receive notice of all AE/SAEs you submit.
SAEs deemed unexpected and related will be designated high priority and may require prompt feedback from you in order to meet NCI and FDA reporting requirements
to ensure clarity and accuracy of the information provided
The timeline for reporting to regulatory authorities begins with your submission
time is an important factor
5 calendar days for fatal and life-threatening unexpected, related SAE
10 calendar days for all other unexpected, related SAE

65. Variations…
In addition to the previously stated expectations it is important to note
Foundation Studies (3500 series) will
Require the completion of an SAE Report Form in place of AdEERS
RTOG will transcribe the information provided to the FDA MedWatch platform and report to regulatory authorities
Likely require additional input form the reporter and or investigator.
The site will receive a copy of the MedWatch when submitted

66. AE/SAE Coordinator
Sara McCartney

67. The NEW FDA Final Rule for Expedited Reporting
The Final Rule:
21 CFR Parts 312 and 320 [Docket No. FDA-2000-N-0108] (formerly Docket No. 00N-1484)
RIN 0910-AG13
Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
This regulation requires changes to expedited serious adverse event reporting requirements for investigators to IND sponsors such as NCI/CTEP

68. Pharmaceutical/Industry SAE Reporting Requirements
Special considerations when reporting on pharmaceutically supported studies using the AdEERS system
Pharmaceutically supported studies often require additional reporting over and above that which is required by the NCI.
Complying with pharmaceutical standards will require bypassing the “reporting not required” screen in AdEERS and going on to complete and submit the report.

69. SAE Definition
A Serious Adverse Event (SAE) is defined by the Code of Federal
Regulations (CFR) as:
Any untoward medical occurrence that at any dose results in
death
is life threatening
requires inpatient hospitalization or prolongation of existing hospitalization
results in persistent or significant disability/incapacity
or is a congenital anomaly/birth defect.
The phrase “at any dose” should be replaced with “during protocol treatment
and 30 days after” for RTOG purposes to capture SAEs that occur during any
part of protocol therapy including radiation therapy or surgery.
Please note reporting outside the 30 day window is required when the event is
determined to be possibly, probably or definitely related to any part of protocol
treatment.

70. Important Points
Hospitalization is defined as an admission to an inpatient bed for at least 24 hours.
Grade, attribution or expectedness are not a consideration for RTOG in the reporting of SAEs, simply meeting the criteria in the SAE definition makes the event an SAE.
The new FDA Final Rule RE: Expedited Reporting now also requires all SAEs be reported unless the protocol states otherwise

71. Medically Significant Events
Medical and scientific judgment should be exercised in deciding whether reporting as an SAE is appropriate in other situations, such as important medical events that may not be immediately life threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent one of the outcomes listed in the SAE definition.

72. Site Initiated SAE/Safety Reporting
Reporting Serious Adverse Events (SAE)
AdEERS is the required reporting format for SAEs on all NCI supported RTOG studies
A study specific SAE form will be used for upcoming Foundation Studies (3500 series studies) for transcription by RTOG into the FDA MedWatch Form
All events that meet the criteria for an SAE must be reported regardless of grade or attribution
SAE/Safety Reporting is separate, and in addition to Data Management AE reporting (on the CRF)
All SAEs must be reported to your IRB

73. SAE
Serious Adverse Events (SAEs) are defined by FDA and therefore
seriousness (not severity) serves as a guide for defining regulatory
reporting obligations for patient/subject safety. ‘Seriousness’ is based on
patient/event outcome or action criteria usually associated with events
that pose a threat to a patient’s life or functioning. FDA Federal
Regulations require IND sponsors to report serious adverse events via
Expedited reporting.
The two terms “serious” and “severe” are not interchangeable and their meanings should not be confused.

74. 24 Hour AdEERS Notification Requirements
Late Phase II & Phase III Studies: all grade 4 & 5 events regardless of relationship
Phase I & early Phase II Studies: all grade 3, 4 & 5 events regardless of relationship

75. 24 Hour AdEERS Notification Requirements
The timeframe for the complete AdEERS Report associated with any 24 Hour AdEERS Notifications is 5 days.
All other SAEs that do not require the submission of a 24 Hour AdEERS Notification will be reported via AdEERS using the 10 day reporting timeline.

76. Foundation Study SAE Report Form (SAERF) 24 Hour Notification Requirements
Late Phase II & Phase III Studies: all grade 4 & 5 events regardless of relationship
Phase I & early Phase II Studies: all grade 3, 4 & 5 events regardless of relationship
The timeframe for the complete Report associated with any event requiring 24 Hour Notifications is 5 days.
All other SAEs that do not require the submission of a 24 Hour Notification will be reported using the 10 day reporting timeline.

77. Timelines
The time frame for submitting the required type of report will vary from FIVE to TEN CALENDAR DAYS Please refer to the protocol for specifics
The day the event is reported is counted as day one.
The reporting deadline is required to allow for RTOG and/or pharmaceutical sponsors to fulfill their external regulatory reporting obligations.

78. Proper Identification
Proper identification of follow-up or amended reports,
supporting source documentation and/or other information
relevant to the SAE is imperative and must always include
the RTOG study and case number
Please use the RTOG Case Number as the Patient ID in the AdEERS System * DO NOT ADD LEADING ZEROS
Please follow the specific instructions on the SAE Report Form for Foundation (3500 series) studies

79. What type of other documentation must be submitted with the an SAE Report?
AdEERS: Only documentation noted by the reporter as being provided in the additional information section of AdEERS need be submitted initially
Foundation (3500 series)SAE Report Form: None unless specifically requested
If the pharmaceutical company requires further documentation or clarification, RTOG will contact you via with the query/ request
The NCI may also contact you directly to request specific information or documentation

80. 215-717-0990 Dedicated SAE Fax Line
All necessary supporting source documentation relating to the SAE noted as being supplied in the Additional Information Section of the AdEERS Report must be properly labeled with the RTOG Study and Case Number as well as the date and Ticket Number of the corresponding event and provided within the allotted timeframe or as soon as it becomes available.
Information pertaining to Foundation (3500 series) Studies must also be properly labeled with the Study and Case Number as well as the date of the event

81. May 27, 2008

82. Guidance and/or Assistance with the AdEERS System
It may be helpful to view the AdEERS Tutorial at the following link:
Problems or issues with the AdEERS System for reporting AE/SAEs may also be referred to the following contacts:
For all medical and policy related issues, please contact the AdEERS Coordinators by at or telephone (301)
For all technical and training related issues please contact the NCI CTEP Help Desk by at or telephone (301)
RTOG AdEERS Coordinators for:
SAEs – contact AE Coordinator Sara McCartney

83. Guidance and/or Assistance with the Foundation (3500 series) SAE Report Form
You can view both the Foundation SAE Report Form and Guidance for use/completion on the RTOG website .
The Foundation SAE Report Form and Guidance are study specific and will be located under the study specific Regulatory Resources tab on the website
The RTOG SAE Coordinator: Sara McCartney[ or can also provide assistance with using the Foundation SAE Report Form

84. NCI/Pharmaceutical Initiated/External Safety Reports (ESR)
Events detailed in safety reports originating from the NCI or pharmaceutical company can reference a more global use of the drug
These safety reports are intended to inform treating physicians regarding events that have occurred in the interim that will be included in the next revised Investigator Brochure
No action other than providing these reports to your IRB is required unless indicated
Any questions regarding the overall significance of events reported in these safety reports should be directed to the NCI or the pharmaceutical company that initiated the report.

85. External Safety Report (ESR) IRB Review
Local IRB policy can limit the review of ESRs
Auditors will require a copy of the written IRB policy or SOP
In the event the Local IRB elects not to review all ESRs
ESRs must still be reviewed by the PI or designee
The reviewer should indicate review by signing and dating the report
All ESRs must still be maintained as part of the study file for review during a site audit.
Sites who previously relied on the CIRB review of ESRs for Phase III studies
This review is now accomplished by way of review of the RTOG Data Monitoring Committee (DMC) reports for both Phase IIR & III studies

86. Finding Safety Reports on the Website
Safety Reports can be found under the study specific broadcasts on the RTOG website (Clinical Trials > Protocol Table > Study Details > Broadcasts)
Safety reports are sent via broadcast to individuals from participating institutions who are listed on the RTOG Broadcast List
If you would like to be added/removed from the RTOG broadcast list or wish to update your address, send a message to
Sites should not reply directly to any broadcast. Institutions can share a comment or ask a question by accessing the appropriate department at RTOG Headquarters on the RTOG web site at then select the member information tab and click HQ Information & Telephone Listings. Sites can also call ext. 4189, which provides prompts to reach each department
Canadian research staff should be sure to request they be added specifically to the Canadian Broadcast List to assure the receipt of all broadcast information relevant to Canadian participation

87. Safety Report Broadcasts Clinical Trials > Protocol Table > Study Details > Broadcasts

88. On a Lighter Note…

89. Regulatory Staff

90. ??? ANY QUESTIONS ???