SELECT Study Manual
Section 9: Forms Completion and Data Submission
Form 409 – SELECT Serious Adverse Event Report
Version 1.6 – March 29, 2007
Form 409, Page 1 of 3
SELECT Study Manual
Section 9: Forms Completion and Data Submission
Form 409 – SELECT Serious Adverse Event Report
Fax form and supporting documents to the Southwest Oncology Group
Operations Office in San Antonio at 210-518-9501 or 210-677-0006.
Study Site Staff
Completed by:
In the event of a serious adverse experience if there is a reasonable
When to complete
suspicion that the toxicity is at least possibly related to the Study
and submit:
Supplement(s). See Section 16.0 of the SELECT protocol (S0000).
N/A
Contact Number:
*Supplemental documentation required for all items on this form.
Submission:
Guidelines for Reporting Serious Adverse Events (SAEs) Occurring
with Vitamin E and Selenium on S0000:
1. Within 24 hours of first knowledge of the event call the Operations Office at 210-450-8808.
2. Within 10 days, fax to the Operations Office:
a) The signed Form 409 – SELECT Serious Adverse Event Report
b) Copies of clinical data documenting the Serious Adverse Event (e.g., hospital discharge
summaries, death certificates)
c) IRB notification documentation
d) Any other data requested during telephonic report
3. In addition, follow the guidelines below.
What Must Be Reported:
Form 409 – SELECT Serious Adverse Event Report must be submitted if there is a reasonable
suspicion that the toxicity is at least possibly related to the Study Supplement(s).
All Grades 3–5 Unexpected Reactions and Grades 4–5 Expected Reactions, according to the current
version of NCI CTC (see Section 19.1 of the SELECT Protocol (S0000)), must be reported as SAEs if
there is a reasonable suspicion that the toxicity is at least possibly related to the Study Supplement(s).
New diagnoses of cancer, including prostate cancer, in SELECT participants need not be reported as
serious adverse events. Report endpoints to the SELECT Statistical Center as described in Section 8
– Endpoints.
Reports of all Grades 3–5 Unexpected Reactions and Grades 4–5 Expected Reactions determined to
be at least possibly related to either of the Study Supplements will be forwarded from the Operations
Office to the FDA (as per the Code of Federal Regulations, 21 CFR 312.32).
Form Instructions:
Most fields on this form may be completed online or the form may be printed and filled out by hand.
The form must be printed out, signed, and then faxed to the Southwest Oncology Group Operations
Office at the number listed above. This form is not web-submitted.
Toxicity and Toxicity Grade
For grading reactions, see Version 2.0 of the NCI Common Toxicity Criteria in Appendix 19.1 of the
SELECT Protocol (S0000).
Version 1.6 – March 29, 2007
Form 409, Page 2 of 3
SELECT Study Manual
Section 9: Forms Completion and Data Submission
Toxicity Category
If the toxicity is an Expected Reaction, mark Expected. If the toxicity is an Unexpected Reaction,
mark Unexpected. In the case of toxicity resulting in death, mark Death. Choose only one category.
Expected toxicities are listed in the Drug Information, Background sections, and/or in the model
Informed Consent in the SELECT Protocol (S0000).
Attribution:
Form 409 – SELECT Serious Adverse Event Report must be submitted if there is a reasonable
suspicion that the toxicity is at least Possibly related to the Study Supplement(s).
Reactions judged Definitely Not Study Supplement-related should not be reported. All deaths while
on protocol or within 30 days after last taking Study Supplements must be reported, unless considered
Definitely Not Study Supplement-related. Any death more than 30 days after discontinuing Study
Supplements which is thought to be Study Supplement-related must also be reported.
Keep this form and copies of supporting documentation on file. See Section 16.0 of the SELECT
Protocol (S0000) for additional information on serious adverse events and this form.
Version 1.6 – March 29, 2007
Form 409, Page 3 of 3