NCI National Clinical Trials Network (NCTN) Program Guidelines
NCI National Clinical Trials Network (NCTN) Program Guidelines NCI National Clinical Trials Network (NCTN) Program Guidelines
PART 2: Submission of New/Competing Application Section III.B.2.6 – Review Criteria Canadian Collaborating Clinical Trials Network trial data and timely reporting to the institutions/sites of this information that indicate its potential to operative efficiently within the NCTN Program? Do the facilities and equipment (including computer hardware and software) available as well as the information technology (IT) support for central storage, security, analysis and retrieval of clinical data for the proposed Canadian Collaborating Clinical Trials Network appear adequate for clinical trial research? Does the proposed Canadian Collaborating Clinical Trials Network have policies and procedures in place that are in compliance with federal regulations related to confidentiality of patient data, including Health Insurance Portability and Accountability Act (HIPAA) regulations for NCTN-related activities? 2.6.6 Additional Review Item D - Program for Collaborations & Participation in Collective Management Collaborations with NCTN Network Groups, NCTN Programs/Initiatives, and other NCI-sponsored Programs/Investigators: Does the applicant have a track record for collaborations with other trial organizations and NCI-sponsored programs and investigators on clinical trials and translational science studies that demonstrates its potential for collaboration within the NCTN Program? Collective Management Activities: Does that applicant have a track record that demonstrates that the members of its scientific leadership teams (i.e., scientific research committee members) actively participate in or can actively contribute to NCI clinical trial activities (e.g., disease-specific and modality-specific Scientific Steering Committees and related task forces or working Groups, Clinical Trials Planning Committees for meetings supported by the NCI disease-specific Steering Committees, participation in other NCI programs and initiatives related to clinical research)? Page 182 of 241
PART 2: Submission of New/Competing Application Section III – Other NCTN Review Criteria & Info 3. Additional Review Criteria – Overall – for All Key Components of the NCTN Program As applicable for the clinical research that the applicant for a key component under the NCTN program has proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact/priority score, but will not give separate scores for these items. 3.1 Protections of Human Subjects For research that involves human subjects but does not involve one of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials. For research that involves human subjects and meets the criteria for one or more of the six categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Human Subjects Protection and Inclusion Guidelines. 3.2 Inclusion of Women, Minorities, and Children When the proposed key component of the NCTN Program involves clinical research, the committee will evaluate the proposed plans for inclusion of minorities and members of both genders, as well as the inclusion of children. For additional information on review of the Inclusion section, please refer to the Human Subjects Protection and Inclusion Guidelines. 3.3 Vertebrate Animals The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following five points: 1) proposed use of the animals, and species, strains, ages, sex, and numbers to be used; 2) justifications for the use of animals and for the appropriateness of the species and numbers proposed; 3) adequacy of veterinary care; 4) procedures for limiting discomfort, distress, pain and injury to that which is unavoidable in the conduct of scientifically sound research including the use of analgesic, anesthetic, and tranquilizing drugs and/or comfortable restraining devices; and 5) methods of euthanasia and reason for selection if not consistent with the AVMA Guidelines on Euthanasia. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section. 3.4 Biohazards Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed. 3.5 Resubmissions, Renewals, and Revisions Resubmissions, renewals, and revisions are not applicable at the current time for NCTN Program. 4. Additional Review Considerations – Overall – for All Key Components of the NCTN Program As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact/priority score. Page 183 of 241
- Page 131 and 132: PART 2: Submission of New/Competing
- Page 133 and 134: PART 2: Submission of New/Competing
- Page 135 and 136: PART 2: Submission of New/Competing
- Page 137 and 138: PART 2: Submission of New/Competing
- Page 139 and 140: PART 2: Submission of New/Competing
- Page 141 and 142: PART 2: Submission of New/Competing
- Page 143 and 144: PART 2: Submission of New/Competing
- Page 145 and 146: PART 2: Submission of New/Competing
- Page 147 and 148: PART 2: Submission of New/Competing
- Page 149 and 150: PART 2: Submission of New/Competing
- Page 151 and 152: PART 2: Submission of New/Competing
- Page 153 and 154: PART 2: Submission of New/Competing
- Page 155 and 156: PART 2: Submission of New/Competing
- Page 157 and 158: PART 2: Submission of New/Competing
- Page 159 and 160: PART 2: Submission of New/Competing
- Page 161 and 162: PART 2: Submission of New/Competing
- Page 163 and 164: PART 2: Submission of New/Competing
- Page 165 and 166: PART 2: Submission of New/Competing
- Page 167 and 168: PART 2: Submission of New/Competing
- Page 169 and 170: PART 2: Submission of New/Competing
- Page 171 and 172: PART 2: Submission of New/Competing
- Page 173 and 174: PART 2: Submission of New/Competing
- Page 175 and 176: PART 2: Submission of New/Competing
- Page 177 and 178: PART 2: Submission of New/Competing
- Page 179 and 180: PART 2: Submission of New/Competing
- Page 181: PART 2: Submission of New/Competing
- Page 185 and 186: PART 2: Submission of New/Competing
- Page 187 and 188: PART 3: Submission of Non-Competing
- Page 189 and 190: TYPE OF STUDY PART 3: Submission No
- Page 191 and 192: PART 3: Submission Non-Competing Ap
- Page 193 and 194: PART 3: Submission Non-Competing Ap
- Page 195 and 196: PART 4: Appendices Section II - Req
- Page 197 and 198: PART 4: Appendices Section II - Req
- Page 199 and 200: PART 4: Appendices Section II - Req
- Page 201 and 202: Participating Site Member Category
- Page 203 and 204: PART 4: Appendices Section II - Req
- Page 205 and 206: PART 4: Appendices Section II - Req
- Page 207 and 208: PART 4: Appendices Section II - Req
- Page 209 and 210: PART 4: Appendices Section II - Req
- Page 211 and 212: PART 4: Appendices Section IV - Cos
- Page 213 and 214: PART 4: Appendices Section IV - Cos
- Page 215 and 216: PART 4: Appendices Section IV - Cos
- Page 217 and 218: PART 4: Appendices Section V - Impo
- Page 219 and 220: PART 4: Appendices Section V - Impo
- Page 221 and 222: PART 4: Appendices Section V - Impo
- Page 223 and 224: Part 4: Appendices - VI. Sample Tab
- Page 225 and 226: Part 4: Appendices - VII. Model for
- Page 227 and 228: Part 4: Appendices - VII. NCTN Prog
- Page 229 and 230: Part 4: Appendices - VII. NCTN Prog
- Page 231 and 232: Part 4: Appendices - VII. NCTN Prog
PART 2: Submission of New/Competing Application Section III.B.2.6 – Review Criteria<br />
Canadian Collaborating <strong>Clinical</strong> <strong>Trials</strong> <strong>Network</strong><br />
trial data and timely reporting to the institutions/sites of this information that<br />
indicate its potential to operative efficiently within the <strong>NCTN</strong> <strong>Program</strong>?<br />
Do the facilities and equipment (including computer hardware and software) available<br />
as well as the information technology (IT) support for central storage, security,<br />
analysis and retrieval of clinical data for the proposed Canadian Collaborating <strong>Clinical</strong><br />
<strong>Trials</strong> <strong>Network</strong> appear adequate for clinical trial research? Does the proposed<br />
Canadian Collaborating <strong>Clinical</strong> <strong>Trials</strong> <strong>Network</strong> have policies and procedures in place<br />
that are in compliance with federal regulations related to confidentiality of patient<br />
data, including Health Insurance Portability and Accountability Act (HIPAA) regulations<br />
for <strong>NCTN</strong>-related activities?<br />
2.6.6 Additional Review Item D - <strong>Program</strong> for Collaborations & Participation in Collective<br />
Management<br />
Collaborations with <strong>NCTN</strong> <strong>Network</strong> Groups, <strong>NCTN</strong> <strong>Program</strong>s/Initiatives, and other<br />
<strong>NCI</strong>-sponsored <strong>Program</strong>s/Investigators: Does the applicant have a track record for<br />
collaborations with other trial organizations and <strong>NCI</strong>-sponsored programs and<br />
investigators on clinical trials and translational science studies that demonstrates its<br />
potential for collaboration within the <strong>NCTN</strong> <strong>Program</strong>?<br />
Collective Management Activities: Does that applicant have a track record that<br />
demonstrates that the members of its scientific leadership teams (i.e., scientific<br />
research committee members) actively participate in or can actively contribute to <strong>NCI</strong><br />
clinical trial activities (e.g., disease-specific and modality-specific Scientific Steering<br />
Committees and related task forces or working Groups, <strong>Clinical</strong> <strong>Trials</strong> Planning<br />
Committees for meetings supported by the <strong>NCI</strong> disease-specific Steering Committees,<br />
participation in other <strong>NCI</strong> programs and initiatives related to clinical research)?<br />
Page 182 of 241